Recruiting NCT04300998
Study of CAR-T Therapy in Older Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Activities of Daily Living/ADLs, Instrumental Activity of Daily Living, Timed Up and Go, Cognition.
- Who it may be relevant to
- Registry conditions: Lymphoma, Refractory B-Cell Lymphoma, Lymphoma, B-Cell, DLBCL NOS. Basic parameters: from 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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
- 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.
Primary outcome measures
- Number of participants who complete all required assessment visits prior to disease progression or death [Time frame: 1 year]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Memorial Sloan Kettering Cancer Center — New York
Identifiers
NCT: NCT04300998 · 19-452