RecruitingNCT04300998

Study of CAR-T Therapy in Older Patients

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

Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

154 participants

Start Date

Mar 4, 2020

Study Type

OBSERVATIONAL

Conditions

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

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.

Eligibility

Min Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at how CAR-T cell therapy (a type of personalized immune cell treatment) affects older patients — including their thinking skills, physical function, and overall quality of life. Researchers also want to understand the specific challenges faced by older adults receiving this cutting-edge cancer treatment. **You may be eligible if...** - You are at least 60 years old - You have a confirmed diagnosis of a relapsed or treatment-resistant blood cancer or plasma cell disorder (such as certain lymphomas or multiple myeloma) - You are receiving a commercially approved CAR-T cell therapy - You can speak and understand English (for certain study groups) **You may NOT be eligible if...** - You have previously received any CAR-T cell therapy (commercial or experimental) - You have a current diagnosis of major depression, bipolar disorder, or schizophrenia (for some study groups) - You have a history of a major neurological condition or brain injury with extended loss of consciousness Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALActivities 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

BEHAVIORALInstrumental 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.

BEHAVIORALTimed 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)

BEHAVIORALCognition

Mini-Cognition test: CDT and 3-word recall

BEHAVIORALGeriatric 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.

BEHAVIORALSocial 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.

BEHAVIORALBrief Test of Attention

assess selective auditory attention.

BEHAVIORALTrail Making Test

Assesses visual scanning, graphomotor speed, and set shifting.

BEHAVIORALControlled Oral Word Association Test

A timed test of verbal fluency

BEHAVIORALHopkins 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.

OTHERBlood draw

collection of blood tests