Study of CAR-T Therapy in Older Patients
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Behavioral: Activities 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
Other Names:
Behavioral: Instrumental 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.
Other Names:
Behavioral: Timed 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)
Behavioral: Cognition
Mini-Cognition test: CDT and 3-word recall
Behavioral: Geriatric 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.
Behavioral: Social 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.
Behavioral: Brief Test of Attention
assess selective auditory attention.
Other Names:
Behavioral: Trail Making Test
Assesses visual scanning, graphomotor speed, and set shifting.
Behavioral: Controlled Oral Word Association Test
A timed test of verbal fluency
Other Names:
Behavioral: Hopkins 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.
Other Names:
|
| older patients with lymphoma and other lymphoid malignancies This is a prospective observational cohort where 100 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. |
Behavioral: Activities 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
Other Names:
Behavioral: Instrumental 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.
Other Names:
Behavioral: Timed 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)
Behavioral: Cognition
Mini-Cognition test: CDT and 3-word recall
Behavioral: Geriatric 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.
Behavioral: Social 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.
Behavioral: Brief Test of Attention
assess selective auditory attention.
Other Names:
Behavioral: Trail Making Test
Assesses visual scanning, graphomotor speed, and set shifting.
Behavioral: Controlled Oral Word Association Test
A timed test of verbal fluency
Other Names:
Behavioral: Hopkins 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.
Other Names:
Other: Blood draw
collection of blood tests
|
| older patients with myeloma and other plasma cell disorders This is a prospective observational cohort where 60 older patients (≥60yo) undergoing CAR T therapy for relapsed refractory plasma cell disorders will undergo |
Behavioral: Activities 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
Other Names:
Behavioral: Instrumental 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.
Other Names:
Behavioral: Timed 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)
Behavioral: Cognition
Mini-Cognition test: CDT and 3-word recall
Behavioral: Geriatric 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.
Behavioral: Social 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.
Behavioral: Brief Test of Attention
assess selective auditory attention.
Other Names:
Behavioral: Trail Making Test
Assesses visual scanning, graphomotor speed, and set shifting.
Behavioral: Controlled Oral Word Association Test
A timed test of verbal fluency
Other Names:
Behavioral: Hopkins 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.
Other Names:
Other: Blood draw
collection of blood tests
|
Outcome Measures
Primary Outcome Measures
- Number of participants who complete all required assessment visits prior to disease progression or death [1 year]
Participants who complete all assessment visits prior to disease progression or death will be considered as a success for a feasibility endpoint.
Eligibility Criteria
Criteria
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 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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Memorial Sloan Kettering Cancer Center | New York | New York | United States | 10065 |
Sponsors and Collaborators
- Memorial Sloan Kettering Cancer Center
Investigators
- Principal Investigator: Richard Lin, MD, PhD, Memorial Sloan Kettering Cancer Center
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 19-452