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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04300998
Other study ID # 19-452
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 4, 2020
Est. completion date March 4, 2025

Study information

Verified date April 2024
Source Memorial Sloan Kettering Cancer Center
Contact Richard Lin, MD, PhD
Phone 646-608-2646
Email ABMTTrials@mskcc.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 70
Est. completion date March 4, 2025
Est. primary completion date March 4, 2025
Accepts healthy volunteers No
Gender All
Age group 60 Years and older
Eligibility 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)

Study Design


Intervention

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
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.
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)
Cognition
Mini-Cognition test: CDT and 3-word recall
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.
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.
Brief Test of Attention
assess selective auditory attention.
Trail Making Test
Assesses visual scanning, graphomotor speed, and set shifting.
Controlled Oral Word Association Test
A timed test of verbal fluency
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

Country Name City State
United States Memorial Sloan Kettering Cancer Center New York New York

Sponsors (1)

Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of participants who complete all required assessment visits prior to disease progression or death Participants who complete all assessment visits prior to disease progression or death will be considered as a success for a feasibility endpoint. 1 year
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