RecruitingObservational

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

NCT ID: NCT04300998Sponsor: Memorial Sloan Kettering Cancer CenterLast updated: 2026-04-07

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.

Arms & interventions

BehavioralActivities of Daily Living/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
BehavioralInstrumental Activity of Daily Living
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.
BehavioralTimed Up and Go
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)
BehavioralCognition
Mini-Cognition test: CDT and 3-word recall
BehavioralGeriatric Depression Scale
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.
BehavioralSocial Support
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.
BehavioralBrief Test of Attention
assess selective auditory attention.
BehavioralTrail Making Test
Assesses visual scanning, graphomotor speed, and set shifting.
BehavioralControlled Oral Word Association Test
A timed test of verbal fluency
BehavioralHopkins Verbal Learning Test-Revised
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.
OtherBlood draw
collection of blood tests

Outcome measures

Primary

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.
Time frame: 1 year

Eligibility criteria

Sex: AllAge: 60 Years and olderHealthy volunteers: No

Inclusion Criteria: * 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) Exclusion Criteria: * 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)

Study locations (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

Recruiting

Richard Lin, MD, PhD · Contact

ABMTTrials@mskcc.org