Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04300998

Study of CAR-T Therapy in Older Patients

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Lymphoma Blood Protein Disorders Cardiovascular Diseases DLBCL NOS Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders High-grade B-cell Lymphoma Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma, B-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Multiple Myeloma Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Refractory B-Cell Lymphoma Vascular Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

Location status: Recruiting

Location contact

Richard Lin, MD, PhD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Activities of Daily Living/ADLs

Behavioral

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

Instrumental Activity of Daily Living

Behavioral

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

Timed Up and Go

Behavioral

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)

Cognition

Behavioral

Mini-Cognition test: CDT and 3-word recall

Geriatric Depression Scale

Behavioral

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.

Social Support

Behavioral

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.

Brief Test of Attention

Behavioral

assess selective auditory attention.

Other names: BTA

Trail making test

Behavioral

Assesses visual scanning, graphomotor speed, and set shifting.

Controlled Oral Word Association Test

Behavioral

A timed test of verbal fluency

Other names: COWAT

Hopkins Verbal Learning Test-Revised

Behavioral

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

Blood Draw

Other

collection of blood tests

Primary outcomes

  1. Number of participants who complete all required assessment visits prior to disease progression or death

    Time frame: 1 year

    Participants who complete all assessment visits prior to disease progression or death will be considered as a success for a feasibility endpoint.

Study contacts

Contact information is provided by the study sponsor or research team.

Richard Lin, MD, PhD

CONTACT

[email protected]

646-608-2646

Sergio Giralt, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Mar 9, 2020
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.