LymphomaNCT04300998
Study of CAR-T Therapy in Older Patients
An observational study of Lymphoma and Refractory B-Cell Lymphoma, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
This study is being done to find out how older patients respond to CAR-T cell therapy and how the treatment affects their quality of life. This is a quality of life study and participating in the study does not involve receiving any treatment, other than the standard treatment for participants' disease. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Lymphoma, Refractory B-Cell Lymphoma, Lymphoma, B-Cell
- What is being tested?
- Activities of Daily Living/ADLs, Instrumental Activity of Daily Living and Timed Up and Go
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- How many people
- 154 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Mar 2020to 4 Mar 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects will be recruited from all oncologists and all transplant physicians at the Memorial Sloan Kettering Cancer Center. Patients are recruited without consideration of gender, country of origin, educational level, or income. There will be no reimbursement or payment toward the participation of this study.
Who may be able to join
- are ≥60 years old (all cohorts)
- have pathologically confirmed, relapsed refractory lymphoid malignancy or plasma cell disorder receiving a commercial CAR T-cell product (all cohorts)
- able to speak and understand English (cohort 1 and 4 only)
- have a MoCA score of less than 26 out of 30 during the GA visit by a geriatrician prior to CAR T-cell treatment (cohort 4 only)
Who cannot join
- Any prior commercial or investigational CAR T therapy (all cohorts)
- Current diagnosis of major Axis I psychiatric disorder (DSM-IV), major depression, bipolar disorder, or schizophrenia, as per medical records or patient report (cohort 1 only)
- History of a neurological disorder, neurodegenerative disease, or traumatic brain injury with loss of consciousness (>60 minutes), as per medical records or patient report (cohort 1 only)
- Current ongoing substance abuse and/or history of substance abuse, as per medical records or patient report (cohort 1 only)
- History of CNS disease (cohort 4 only)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sergio Giralt, MD contact
United States1 site, 1 recruiting
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Richard Lin, MD, PhD, ABMTTrials@mskcc.org
About this study
Official title: Observational Study of Commercial Chimeric Antigen Receptor T-cell (CAR T) Therapy in Older Patients With Hematologic Malignancies and With an Embedded Pilot Study of Longitudinal Geriatric and Neurocognitive Evaluation
This study is being done to find out how older patients respond to CAR-T cell therapy and how the treatment affects their quality of life. This is a quality of life study and participating in the study does not involve receiving any treatment, other than the standard treatment for participants' disease.
- Conditions
- Lymphoma, Refractory B-Cell Lymphoma, Lymphoma, B-Cell, DLBCL NOS, High-grade B-cell Lymphoma, Multiple Myeloma
- Being tested
- Activities of Daily Living/ADLs, Instrumental Activity of Daily Living, Timed Up and Go, Cognition, Geriatric Depression Scale
- Keywords
- Lymphoma, CART therapy, relapsed refractory large B-cell lymphoma, High-grade B-cell Lymphoma, DLBCL NOS, Refractory B-Cell Lymphoma, 19-452, Memorial Sloan Kettering Cancer Center
- Medical subject headings
- Lymphoma, Lymphoma, B-Cell, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activities of Daily Living/ADLsBehavioural
Also called ADLs
7 activities: bathing, dressing, grooming, feeding, walking inside the home, walking outside the home, and bladder and bowel control. Participants get 2 points for each activity that is not limited at all, 1 point for limited a little, and 0 points for limited a lot. Total ADL score ranges from 0 to 14
Instrumental Activity of Daily LivingBehavioural
Also called iADLS
8 activities: telephone use, doing laundry, shopping, preparing meals, doing housework, handling own medications, handling money and finances, and transportation to visit one's doctor. Participants get 2 points for each activity that can be done without help, 1 point for needing some help, and 0 point for being unable to do. Total iADL score ranges from 0 to16.
Timed Up and GoBehavioural
Participants are asked to get up from the chair, walk 10 feet, turn, and walk back to the char (<10 seconds, 10-20 seconds, >20 seconds)
CognitionBehavioural
Mini-Cognition test: CDT and 3-word recall
Geriatric Depression ScaleBehavioural
Four yes/no questions regarding patient's psychological status. Score ranges from 0 to 4, and a score of >/=1 is usually indicative of depression.
Social SupportBehavioural
Four 5-point Likert scale questions addressing 4 domains of social support: emotional/ informational, tangible, affectionate, and positive social interaction. Score for each item ranges from 1 to 5, and total score ranges from 4 to 20. A higher score means better social support.
Brief Test of AttentionBehavioural
Also called BTA
assess selective auditory attention.
Trail Making TestBehavioural
Assesses visual scanning, graphomotor speed, and set shifting.
Controlled Oral Word Association TestBehavioural
Also called COWAT
A timed test of verbal fluency
Hopkins Verbal Learning Test-RevisedBehavioural
Also called HVLT-R
The HVLT-R is a test of verbal learning and recall. Scores obtained are the total number of words: 1) recalled over three trials; 2)recalled after a delay; 3) correctly recognized.
Blood drawOther
collection of blood tests
| Study group | Role | What they receive |
|---|---|---|
| older lymphoma patients | This is a prospective observational cohort where 18 older patients (≥60yo) undergoing CAR T therapy for relapsed refractory high-grade B-cell lymphoma will undergo serial comprehensive geriatric assessment, neurocognitive testing, and quality of life evaluation prior to and following CAR T therapy. The standard follow-up period is one year. Receives: Behavioral: Activities of Daily Living/ADLs; Behavioral: Instrumental Activity of Daily Living; Behavioral: Timed Up and Go; Behavioral: Cognition; Behavioral: Geriatric Depression Scale; Behavioral: Social Support; Behavioral: Brief Test of Attention; Behavioral: Trail Making Test; Behavioral: Controlled Oral Word Association Test; Behavioral: Hopkins Verbal Learning Test-Revised | |
| older patients with lymphoma and other lymphoid malignancies | This is a prospective observational cohort where 80 older patients (≥60yo) undergoing CAR T therapy for relapsed refractory lymphoma and lymphoid malignancies will undergo comprehensive geriatric assessment, aging biomarker analysis, and quality of life evaluation prior to and following CAR T therapy. The standard follow-up period is one year. Receives: Behavioral: Activities of Daily Living/ADLs; Behavioral: Instrumental Activity of Daily Living; Behavioral: Timed Up and Go; Behavioral: Cognition; Behavioral: Geriatric Depression Scale; Behavioral: Social Support; Behavioral: Brief Test of Attention; Behavioral: Trail Making Test; Behavioral: Controlled Oral Word Association Test; Behavioral: Hopkins Verbal Learning Test-Revised; Other: Blood draw | |
| older patients with myeloma and other plasma cell disorders | This is a prospective observational cohort where 40 older patients (≥60yo) undergoing CAR T therapy for relapsed refractory plasma cell disorders will undergo Receives: Behavioral: Activities of Daily Living/ADLs; Behavioral: Instrumental Activity of Daily Living; Behavioral: Timed Up and Go; Behavioral: Cognition; Behavioral: Geriatric Depression Scale; Behavioral: Social Support; Behavioral: Brief Test of Attention; Behavioral: Trail Making Test; Behavioral: Controlled Oral Word Association Test; Behavioral: Hopkins Verbal Learning Test-Revised; Other: Blood draw | |
| older patients with lymphoma | This is prospective observational cohort where 16 older (≥60yo) lymphoma patients with pre-CAR T cognitive impairment. Receives: Behavioral: Activities of Daily Living/ADLs; Behavioral: Instrumental Activity of Daily Living; Behavioral: Timed Up and Go; Behavioral: Cognition; Behavioral: Geriatric Depression Scale; Behavioral: Social Support; Behavioral: Brief Test of Attention; Behavioral: Trail Making Test; Behavioral: Controlled Oral Word Association Test; Behavioral: Hopkins Verbal Learning Test-Revised; Other: Blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who complete all required assessment visits prior to disease progression or death
Participants who complete all assessment visits prior to disease progression or death will be considered as a success for a feasibility endpoint.
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 posted9 Mar 2020
- Study start4 Mar 2020
- Primary completion4 Mar 2027 (estimated)
- Study completion4 Mar 2027 (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 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
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard Lin, MD, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04300998
- Sponsor's protocol ID
- 19-452
- Status last verified
- Apr 2026
- First submitted
- 5 Mar 2020
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- 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 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Commercial Chimeric Antigen Receptor T-cell (CAR T) Therapy in Older Patients With Hematologic Malignancies and With an Embedded Pilot Study of Longitudinal Geriatric and Neurocognitive Evaluation
- ClinicalTrials.gov ID
- NCT04300998
- Acronym / sponsor ID
- 19-452
- Conditions
- Lymphoma, Refractory B-Cell Lymphoma, Lymphoma, B-Cell, DLBCL NOS, High-grade B-cell Lymphoma, Multiple Myeloma
- Keywords
- Lymphoma, CART therapy, relapsed refractory large B-cell lymphoma, High-grade B-cell Lymphoma, DLBCL NOS, Refractory B-Cell Lymphoma, 19-452, Memorial Sloan Kettering Cancer Center
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 4 Mar 2020 (actual)
- Primary completion
- 4 Mar 2027 (estimated)
- Study completion
- 4 Mar 2027 (estimated)
- First posted
- 9 Mar 2020 (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.
This study is being done to find out how older patients respond to CAR-T cell therapy and how the treatment affects their quality of life. This is a quality of life study and participating in the study does not involve receiving any treatment, other than the standard treatment for participants' disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| older lymphoma patients | – | Behavioral: Activities of Daily Living/ADLs, Behavioral: Instrumental Activity of Daily Living, Behavioral: Timed Up and Go, Behavioral: Cognition, Behavioral: Geriatric Depression Scale, Behavioral: Social Support, Behavioral: Brief Test of Attention, Behavioral: Trail Making Test, Behavioral: Controlled Oral Word Association Test, Behavioral: Hopkins Verbal Learning Test-RevisedThis is a prospective observational cohort where 18 older patients (≥60yo) undergoing CAR T therapy for relapsed refractory high-grade B-cell lymphoma will undergo serial comprehensive geriatric assessment, neurocognitive testing, and quality of life evaluation prior to and following CAR T therapy. The standard follow-up period is one year. |
| older patients with lymphoma and other lymphoid malignancies | – | Behavioral: Activities of Daily Living/ADLs, Behavioral: Instrumental Activity of Daily Living, Behavioral: Timed Up and Go, Behavioral: Cognition, Behavioral: Geriatric Depression Scale, Behavioral: Social Support, Behavioral: Brief Test of Attention, Behavioral: Trail Making Test, Behavioral: Controlled Oral Word Association Test, Behavioral: Hopkins Verbal Learning Test-Revised, Other: Blood drawThis is a prospective observational cohort where 80 older patients (≥60yo) undergoing CAR T therapy for relapsed refractory lymphoma and lymphoid malignancies will undergo comprehensive geriatric assessment, aging biomarker analysis, and quality of life evaluation prior to and following CAR T therapy. The standard follow-up period is one year. |
| older patients with myeloma and other plasma cell disorders | – | Behavioral: Activities of Daily Living/ADLs, Behavioral: Instrumental Activity of Daily Living, Behavioral: Timed Up and Go, Behavioral: Cognition, Behavioral: Geriatric Depression Scale, Behavioral: Social Support, Behavioral: Brief Test of Attention, Behavioral: Trail Making Test, Behavioral: Controlled Oral Word Association Test, Behavioral: Hopkins Verbal Learning Test-Revised, Other: Blood drawThis is a prospective observational cohort where 40 older patients (≥60yo) undergoing CAR T therapy for relapsed refractory plasma cell disorders will undergo |
| older patients with lymphoma | – | Behavioral: Activities of Daily Living/ADLs, Behavioral: Instrumental Activity of Daily Living, Behavioral: Timed Up and Go, Behavioral: Cognition, Behavioral: Geriatric Depression Scale, Behavioral: Social Support, Behavioral: Brief Test of Attention, Behavioral: Trail Making Test, Behavioral: Controlled Oral Word Association Test, Behavioral: Hopkins Verbal Learning Test-Revised, Other: Blood drawThis is prospective observational cohort where 16 older (≥60yo) lymphoma patients with pre-CAR T cognitive impairment. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be recruited from all oncologists and all transplant physicians at the Memorial Sloan Kettering Cancer Center. Patients are recruited without consideration of gender, country of origin, educational level, or income. There will be no reimbursement or payment toward the participation of this study.
Key inclusion criteria (4 listed)
- are ≥60 years old (all cohorts)
- have pathologically confirmed, relapsed refractory lymphoid malignancy or plasma cell disorder receiving a commercial CAR T-cell product (all cohorts)
- able to speak and understand English (cohort 1 and 4 only)
- have a MoCA score of less than 26 out of 30 during the GA visit by a geriatrician prior to CAR T-cell treatment (cohort 4 only)
Key exclusion criteria (5 listed)
- Any prior commercial or investigational CAR T therapy (all cohorts)
- Current diagnosis of major Axis I psychiatric disorder (DSM-IV), major depression, bipolar disorder, or schizophrenia, as per medical records or patient report (cohort 1 only)
- History of a neurological disorder, neurodegenerative disease, or traumatic brain injury with loss of consciousness (>60 minutes), as per medical records or patient report (cohort 1 only)
- Current ongoing substance abuse and/or history of substance abuse, as per medical records or patient report (cohort 1 only)
- History of CNS disease (cohort 4 only)
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 |
|---|---|---|
| Activities of Daily Living/ADLsAlso: ADLs7 activities: bathing, dressing, grooming, feeding, walking inside the home, walking outside the home, and bladder and bowel control. Participants get 2 points for each activity that is not limited at all, 1 point for limited a little, and 0 points for limited a lot. Total ADL score ranges from 0 to 14 | Behavioural | older lymphoma patients, older patients with lymphoma, older patients with lymphoma and other lymphoid malignancies, older patients with myeloma and other plasma cell disorders |
| Instrumental Activity of Daily LivingAlso: iADLS8 activities: telephone use, doing laundry, shopping, preparing meals, doing housework, handling own medications, handling money and finances, and transportation to visit one's doctor. Participants get 2 points for each activity that can be done without help, 1 point for needing some help, and 0 point for being unable to do. Total iADL score ranges from 0 to16. | Behavioural | older lymphoma patients, older patients with lymphoma, older patients with lymphoma and other lymphoid malignancies, older patients with myeloma and other plasma cell disorders |
| Timed Up and GoParticipants are asked to get up from the chair, walk 10 feet, turn, and walk back to the char (<10 seconds, 10-20 seconds, >20 seconds) | Behavioural | older lymphoma patients, older patients with lymphoma, older patients with lymphoma and other lymphoid malignancies, older patients with myeloma and other plasma cell disorders |
| CognitionMini-Cognition test: CDT and 3-word recall | Behavioural | older lymphoma patients, older patients with lymphoma, older patients with lymphoma and other lymphoid malignancies, older patients with myeloma and other plasma cell disorders |
| Geriatric Depression ScaleFour yes/no questions regarding patient's psychological status. Score ranges from 0 to 4, and a score of >/=1 is usually indicative of depression. | Behavioural | older lymphoma patients, older patients with lymphoma, older patients with lymphoma and other lymphoid malignancies, older patients with myeloma and other plasma cell disorders |
| Social SupportFour 5-point Likert scale questions addressing 4 domains of social support: emotional/ informational, tangible, affectionate, and positive social interaction. Score for each item ranges from 1 to 5, and total score ranges from 4 to 20. A higher score means better social support. | Behavioural | older lymphoma patients, older patients with lymphoma, older patients with lymphoma and other lymphoid malignancies, older patients with myeloma and other plasma cell disorders |
| Brief Test of AttentionAlso: BTAassess selective auditory attention. | Behavioural | older lymphoma patients, older patients with lymphoma, older patients with lymphoma and other lymphoid malignancies, older patients with myeloma and other plasma cell disorders |
| Trail Making TestAssesses visual scanning, graphomotor speed, and set shifting. | Behavioural | older lymphoma patients, older patients with lymphoma, older patients with lymphoma and other lymphoid malignancies, older patients with myeloma and other plasma cell disorders |
| Controlled Oral Word Association TestAlso: COWATA timed test of verbal fluency | Behavioural | older lymphoma patients, older patients with lymphoma, older patients with lymphoma and other lymphoid malignancies, older patients with myeloma and other plasma cell disorders |
| Hopkins Verbal Learning Test-RevisedAlso: HVLT-RThe HVLT-R is a test of verbal learning and recall. Scores obtained are the total number of words: 1) recalled over three trials; 2)recalled after a delay; 3) correctly recognized. | Behavioural | older lymphoma patients, older patients with lymphoma, older patients with lymphoma and other lymphoid malignancies, older patients with myeloma and other plasma cell disorders |
| Blood drawcollection of blood tests | Other | older patients with lymphoma, older patients with lymphoma and other lymphoid malignancies, older patients with myeloma and other plasma cell disorders |
Primary outcome
Number of participants who complete all required assessment visits prior to disease progression or death
Time frame: 1 year
Participants who complete all assessment visits prior to disease progression or death will be considered as a success for a feasibility endpoint.
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 7 Apr 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.
Sergio Giralt, MD contact
Richard Lin, 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 and Refractory B-Cell Lymphoma, 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 4 inclusion and 5 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 7 Apr 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 Richard Lin, MD, PhD (646-608-2646, ABMTTrials@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who complete all required assessment visits prior to disease progression or death (time frame: 1 year). 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 7 Apr 2026; AzTrials last refreshed its copy on 7 Nov 2026.