Study of CAR-T Therapy in Older Patients

Study Overview
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Brief Summary
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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.

Official Title
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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

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

Intervention / Treatment
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* Behavioral: Activities of Daily Living/ADLs
* Behavioral: Instrumental Activity of Daily Living
* Behavioral: Timed Up and Go
* Behavioral: Cognition
* Behavioral: Geriatric Depression Scale
* Behavioral: Social Support
* Behavioral: Brief Test of Attention
* Behavioral: Trail Making Test
* Behavioral: Controlled Oral Word Association Test
* Behavioral: Hopkins Verbal Learning Test-Revised
* Other: Blood draw


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| older lymphoma patients<br>This is a prospective observational cohort where 18 older patients (≥60yo) undergoing CAR T therapy for relapsed refractory high-grade B-cell lymphoma will undergo serial comprehensive geriatric assessment, neurocognitive testing, and quality of life evaluation prior to and following CAR T therapy. The standard follow-up period is one year. | Behavioral: Activities of Daily Living/ADLs<br>* 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<br>* Other names: ADLs;Behavioral: Instrumental Activity of Daily Living<br>* 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.<br>* Other names: iADLS;Behavioral: Timed Up and Go<br>* 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)<br>Behavioral: Cognition<br>* Mini-Cognition test: CDT and 3-word recall<br>Behavioral: Geriatric Depression Scale<br>* 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.<br>Behavioral: Social Support<br>* 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.<br>Behavioral: Brief Test of Attention<br>* assess selective auditory attention.<br>* Other names: BTA;Behavioral: Trail Making Test<br>* Assesses visual scanning, graphomotor speed, and set shifting.<br>Behavioral: Controlled Oral Word Association Test<br>* A timed test of verbal fluency<br>* Other names: COWAT;Behavioral: Hopkins Verbal Learning Test-Revised<br>* 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.<br>* Other names: HVLT-R;|
| older patients with lymphoma and other lymphoid malignancies<br>This is a prospective observational cohort where 80 older patients (≥60yo) undergoing CAR T therapy for relapsed refractory lymphoma and lymphoid malignancies will undergo comprehensive geriatric assessment, aging biomarker analysis, and quality of life evaluation prior to and following CAR T therapy. The standard follow-up period is one year. | Behavioral: Activities of Daily Living/ADLs<br>* 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<br>* Other names: ADLs;Behavioral: Instrumental Activity of Daily Living<br>* 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.<br>* Other names: iADLS;Behavioral: Timed Up and Go<br>* 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)<br>Behavioral: Cognition<br>* Mini-Cognition test: CDT and 3-word recall<br>Behavioral: Geriatric Depression Scale<br>* 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.<br>Behavioral: Social Support<br>* 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.<br>Behavioral: Brief Test of Attention<br>* assess selective auditory attention.<br>* Other names: BTA;Behavioral: Trail Making Test<br>* Assesses visual scanning, graphomotor speed, and set shifting.<br>Behavioral: Controlled Oral Word Association Test<br>* A timed test of verbal fluency<br>* Other names: COWAT;Behavioral: Hopkins Verbal Learning Test-Revised<br>* 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.<br>* Other names: HVLT-R;Other: Blood draw<br>* collection of blood tests<br>|
| older patients with myeloma and other plasma cell disorders<br>This is a prospective observational cohort where 40 older patients (≥60yo) undergoing CAR T therapy for relapsed refractory plasma cell disorders will undergo | Behavioral: Activities of Daily Living/ADLs<br>* 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<br>* Other names: ADLs;Behavioral: Instrumental Activity of Daily Living<br>* 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.<br>* Other names: iADLS;Behavioral: Timed Up and Go<br>* 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)<br>Behavioral: Cognition<br>* Mini-Cognition test: CDT and 3-word recall<br>Behavioral: Geriatric Depression Scale<br>* 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.<br>Behavioral: Social Support<br>* 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.<br>Behavioral: Brief Test of Attention<br>* assess selective auditory attention.<br>* Other names: BTA;Behavioral: Trail Making Test<br>* Assesses visual scanning, graphomotor speed, and set shifting.<br>Behavioral: Controlled Oral Word Association Test<br>* A timed test of verbal fluency<br>* Other names: COWAT;Behavioral: Hopkins Verbal Learning Test-Revised<br>* 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.<br>* Other names: HVLT-R;Other: Blood draw<br>* collection of blood tests<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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