Recruiting

CAR-T Cell Therapy

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT04300998

Conditions

Lymphoma

Refractory B-Cell Lymphoma

Lymphoma, B-Cell

DLBCL NOS

High-grade B-cell Lymphoma

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Interventions

Activities of Daily Living/ADLs

Instrumental Activity of Daily Living

Timed Up and Go

Cognition

Geriatric Depression Scale

Study Details

Brief summary:

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.

Conditions

Lymphoma

Refractory B-Cell Lymphoma

Lymphoma, B-Cell

DLBCL NOS

High-grade B-cell Lymphoma

Study ID

NCT04300998

Start date

Mar 4, 2020

Status verified date

Apr, 2026

Completion date

Mar 4, 2027

Anticipated

Primary completion date

Mar 4, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

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 Design

Enrollment

154 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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.

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

older patients with lymphoma

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

Interventions

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

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.

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)

Cognition

Mini-Cognition test: CDT and 3-word recall

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.

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.

Brief Test of Attention

assess selective auditory attention.

Trail Making Test

Assesses visual scanning, graphomotor speed, and set shifting.

Controlled Oral Word Association Test

A timed test of verbal fluency

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.

Blood draw

collection of blood tests

Primary outcome measure

  • Number of participants who complete all required assessment visits prior to disease progression or death [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Richard Lin, MD, PhD

646-608-2646ABMTTrials@mskcc.org

Sergio Giralt, MD

ABMTTrials@mskcc.org

Locations

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Richard Lin, MD, PhD

ABMTTrials@mskcc.org

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Apr 7, 2026

Last verified

Apr, 2026

Keywords

  • 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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-04-07.