About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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)
Trial 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.
Trial design
Cohort
Prospective
Treatments tested in this trial
Activities of Daily Living/ADLs
Behavioral7 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 Living
Behavioral8 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 Go
BehavioralParticipants 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)
Cognition
BehavioralMini-Cognition test: CDT and 3-word recall
Geriatric Depression Scale
BehavioralFour 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 Support
BehavioralFour 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 Attention
Behavioralassess selective auditory attention.
Trail Making Test
BehavioralAssesses visual scanning, graphomotor speed, and set shifting.
Controlled Oral Word Association Test
BehavioralA timed test of verbal fluency
Hopkins Verbal Learning Test-Revised
BehavioralThe 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 draw
Other interventioncollection of blood tests
Treatment groups
Trial outcomes
Primary outcomes
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.
Sponsors and contacts
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