Lymphoma, Refractory B-Cell Lymphoma, Lymphoma, B-Cell, DLBCL NOS, High-grade B-cell Lymphoma, Multiple Myeloma
Conditions
Keywords
Lymphoma, CART therapy, relapsed refractory large B-cell lymphoma, High-grade B-cell Lymphoma, DLBCL NOS, Refractory B-Cell Lymphoma, 19-452, Memorial Sloan Kettering Cancer Center
Brief 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.
Interventions
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.
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)
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
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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 and 4 only) * have a MoCA score of less than 26 out of 30 during the GA visit by a geriatrician prior to CAR T-cell treatment (cohort 4 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) * History of CNS disease (cohort 4 only)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants who complete all required assessment visits prior to disease progression or death | 1 year | Participants who complete all assessment visits prior to disease progression or death will be considered as a success for a feasibility endpoint. |
Countries
United States
Contacts
Primary ContactRichard Lin, MD, PhD
Backup ContactSergio Giralt, MD
Outcome results
None listed