Study of CAR-T Therapy in Older Patients

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

  • Lymphoma
  • Refractory B-Cell Lymphoma
  • Lymphoma, B-Cell
  • DLBCL NOS
  • High-grade B-cell Lymphoma
  • Multiple Myeloma

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