Study of CAR-T Therapy in Older Patients

Part of paid clinical trials in New York, New York.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT04300998
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Activities of Daily Living/ADLs — BEHAVIORAL
    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
  • Instrumental Activity of Daily Living — BEHAVIORAL
    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.
  • Timed Up and Go — BEHAVIORAL
    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)
  • Cognition — BEHAVIORAL
    Mini-Cognition test: CDT and 3-word recall
  • Geriatric Depression Scale — BEHAVIORAL
    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.
  • Social Support — BEHAVIORAL
    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.
  • Brief Test of Attention — BEHAVIORAL
    assess selective auditory attention.
  • Trail Making Test — BEHAVIORAL
    Assesses visual scanning, graphomotor speed, and set shifting.
  • Controlled Oral Word Association Test — BEHAVIORAL
    A timed test of verbal fluency
  • Hopkins Verbal Learning Test-Revised — BEHAVIORAL
    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.
  • Blood draw — OTHER
    collection of blood tests

Study Details

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.

Key Dates

Start date
Mar 4, 2020
Status verified
Apr 2026
Primary completion
Mar 4, 2027
Completion
Mar 4, 2027

Study Design

Enrollment
154 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.
  • Arm: 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
  • Arm: older patients with lymphoma
    This is prospective observational cohort where 16 older (≥60yo) lymphoma patients with pre-CAR T cognitive impairment.

Primary Outcome Measure

Number of participants who complete all required assessment visits prior to disease progression or death [ Time Frame: 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Richard Lin, MD, PhD
[email protected]

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