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

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.

Study Overview

• Status: Recruiting
• Conditions: Lymphoma; Lymphoma, B-Cell; Multiple Myeloma; High-grade B-cell Lymphoma; Refractory B-Cell Lymphoma; DLBCL NOS
• Intervention / Treatment: 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

• Study Type: Observational
• Enrollment (Estimated): 154

Contacts and Locations

• Study Contact: Name: Sergio Giralt, MD; Email: ABMTTrials@mskcc.org
• Study Contact Backup: Name: Richard Lin, MD, PhD; Phone Number: 646-608-2646; Email: ABMTTrials@mskcc.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Recruiting
      • Memorial Sloan Kettering Cancer Center
      • Contact: Richard Lin, MD, PhD; Email: ABMTTrials@mskcc.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Subjects will be recruited from all oncologists and all transplant physicians at the Memorial Sloan Kettering Cancer Center. Patients are recruited without consideration of gender, country of origin, educational level, or income. There will be no reimbursement or payment toward the participation of this study.

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
older lymphoma patients; 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; 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; Other Names: ADLs; 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.; Other Names: iADLS; 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.; Other Names: BTA; Behavioral: Trail Making Test; Assesses visual scanning, graphomotor speed, and set shifting.; Behavioral: Controlled Oral Word Association Test; A timed test of verbal fluency; Other Names: COWAT; 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 Names: HVLT-R
older patients with lymphoma and other lymphoid malignancies; 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; 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; Other Names: ADLs; 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.; Other Names: iADLS; 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.; Other Names: BTA; Behavioral: Trail Making Test; Assesses visual scanning, graphomotor speed, and set shifting.; Behavioral: Controlled Oral Word Association Test; A timed test of verbal fluency; Other Names: COWAT; 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 Names: HVLT-R; Other: Blood draw; collection of blood tests
older patients with myeloma and other plasma cell disorders; 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; 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; Other Names: ADLs; 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.; Other Names: iADLS; 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.; Other Names: BTA; Behavioral: Trail Making Test; Assesses visual scanning, graphomotor speed, and set shifting.; Behavioral: Controlled Oral Word Association Test; A timed test of verbal fluency; Other Names: COWAT; 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 Names: HVLT-R; Other: Blood draw; collection of blood tests
older patients with lymphoma; This is prospective observational cohort where 16 older (≥60yo) lymphoma patients with pre-CAR T cognitive impairment.	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; Other Names: ADLs; 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.; Other Names: iADLS; 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.; Other Names: BTA; Behavioral: Trail Making Test; Assesses visual scanning, graphomotor speed, and set shifting.; Behavioral: Controlled Oral Word Association Test; A timed test of verbal fluency; Other Names: COWAT; 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 Names: HVLT-R; Other: Blood draw; collection of blood tests

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Investigators: Principal Investigator: Richard Lin, MD, PhD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2020
• Primary Completion (Estimated): March 4, 2027
• Study Completion (Estimated): March 4, 2027

Study Registration Dates

• First Submitted: March 5, 2020
• First Submitted That Met QC Criteria: March 6, 2020
• First Posted (Actual): March 9, 2020

Study Record Updates

• Last Update Posted (Actual): April 7, 2026
• Last Update Submitted That Met QC Criteria: April 1, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Lymphoma; Memorial Sloan Kettering Cancer Center; High-grade B-cell Lymphoma; CART therapy; relapsed refractory large B-cell lymphoma; DLBCL NOS; Refractory B-Cell Lymphoma; 19-452
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Neoplasms, Plasma Cell; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Hemic and Lymphatic Diseases; Lymphoma; Lymphoma, B-Cell; Multiple Myeloma; Investigative Techniques; Therapeutics; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Patient Care; Health Services; Health Care Facilities Workforce and Services; Behavioral Disciplines and Activities; Rehabilitation; Aftercare; Continuity of Patient Care; Psychological Tests; Neuropsychological Tests; Blood Specimen Collection; Trail Making Test; Activities of Daily Living
• Other Study ID Numbers: 19-452

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No