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Purpose

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

Eligibility

Eligible Ages
Over 60 Years
Eligible Sex
All
Accepts Healthy 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 Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
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:
    • ADLs
  • 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:
    • iADLS
  • 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:
    • BTA
  • 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:
    • COWAT
  • 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:
    • HVLT-R
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.
  • 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:
    • ADLs
  • 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:
    • iADLS
  • 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:
    • BTA
  • 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:
    • COWAT
  • 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:
    • HVLT-R
  • Other: Blood draw
    collection of blood tests
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
  • 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:
    • ADLs
  • 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:
    • iADLS
  • 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:
    • BTA
  • 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:
    • COWAT
  • 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:
    • HVLT-R
  • Other: Blood draw
    collection of blood tests
older patients with lymphoma This is prospective observational cohort where 16 older (≥60yo) lymphoma patients with pre-CAR T cognitive impairment.
  • 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:
    • ADLs
  • 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:
    • iADLS
  • 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:
    • BTA
  • 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:
    • COWAT
  • 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:
    • HVLT-R
  • Other: Blood draw
    collection of blood tests

Recruiting Locations

Memorial Sloan Kettering Cancer Center
New York, New York 10065
Contact:
Richard Lin, MD, PhD
ABMTTrials@mskcc.org

More Details

Status
Recruiting
Sponsor
Memorial Sloan Kettering Cancer Center

Study Contact

Richard Lin, MD, PhD
646-608-2646
ABMTTrials@mskcc.org

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.