Study of CAR-T Therapy in Older Patients

Memorial Sloan Kettering Cancer Center (MSK)

Status: Enrolling

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

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

Study type: Observational

Funder types: Other

Identifiers

NCT04300998

19-452

Details and patient eligibility

About

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.

Enrollment: 154 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

154 participants in 4 patient groups

older lymphoma patients

Description:

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.

Treatment:

Behavioral: Trail Making Test

Behavioral: Geriatric Depression Scale

Behavioral: Cognition

Behavioral: Activities of Daily Living/ADLs

Behavioral: Controlled Oral Word Association Test

Behavioral: Brief Test of Attention

Behavioral: Instrumental Activity of Daily Living

Behavioral: Hopkins Verbal Learning Test-Revised

Behavioral: Social Support

Behavioral: Timed Up and Go

older patients with lymphoma and other lymphoid malignancies

Description:

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.

Treatment:

Behavioral: Trail Making Test

Other: Blood draw

Behavioral: Geriatric Depression Scale

Behavioral: Cognition

Behavioral: Activities of Daily Living/ADLs

Behavioral: Controlled Oral Word Association Test

Behavioral: Brief Test of Attention

Behavioral: Instrumental Activity of Daily Living

Behavioral: Hopkins Verbal Learning Test-Revised

Behavioral: Social Support

Behavioral: Timed Up and Go

older patients with myeloma and other plasma cell disorders

Description:

This is a prospective observational cohort where 40 older patients (≥60yo) undergoing CAR T therapy for relapsed refractory plasma cell disorders will undergo

Treatment:

Behavioral: Trail Making Test

Other: Blood draw

Behavioral: Geriatric Depression Scale

Behavioral: Cognition

Behavioral: Activities of Daily Living/ADLs

Behavioral: Controlled Oral Word Association Test

Behavioral: Brief Test of Attention

Behavioral: Instrumental Activity of Daily Living

Behavioral: Hopkins Verbal Learning Test-Revised

Behavioral: Social Support

Behavioral: Timed Up and Go

older patients with lymphoma

Description:

This is prospective observational cohort where 16 older (≥60yo) lymphoma patients with pre-CAR T cognitive impairment.

Treatment:

Behavioral: Trail Making Test

Other: Blood draw

Behavioral: Geriatric Depression Scale

Behavioral: Cognition

Behavioral: Activities of Daily Living/ADLs

Behavioral: Controlled Oral Word Association Test

Behavioral: Brief Test of Attention

Behavioral: Instrumental Activity of Daily Living

Behavioral: Hopkins Verbal Learning Test-Revised

Behavioral: Social Support

Behavioral: Timed Up and Go