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RECRUITING
NCT04300998

Study of CAR-T Therapy in Older Patients

Sponsor: Memorial Sloan Kettering Cancer Center

View on ClinicalTrials.gov

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.

Official title: Observational Study of Commercial Chimeric Antigen Receptor T-cell (CAR T) Therapy in Older Patients With Hematologic Malignancies and With an Embedded Pilot Study of Longitudinal Geriatric and Neurocognitive Evaluation

Key Details

Gender

All

Age Range

60 Years - Any

Study Type

OBSERVATIONAL

Enrollment

154

Start Date

2020-03-04

Completion Date

2027-03-04

Last Updated

2026-04-07

Healthy Volunteers

No

Interventions

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

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.

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.

BEHAVIORAL

Trail Making Test

Assesses visual scanning, graphomotor speed, and set shifting.

BEHAVIORAL

Controlled Oral Word Association Test

A timed test of verbal fluency

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

Blood draw

collection of blood tests

Locations (1)

Memorial Sloan Kettering Cancer Center

New York, New York, United States