NCT04300998

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 154 (estimated)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-03-04
• Primary completion: 2027-03-04
• Completion: 2027-03-04
• First posted: 2020-03-09
• Last updated: 2026-04-07

Locations

1 site across 1 country: United States