CAR-T therapy outcomes and quality of life in older adults with B‑cell lymphoma
Official 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
Run by Memorial Sloan Kettering Cancer Center · NCT04300998 · Data updated 2026-11-12
This project will see how CAR‑T therapy affects older adults (age 60+) with relapsed or refractory B‑cell lymphomas, focusing on daily function and quality of life while they receive standard care.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 60 Years and up |
| Sex | All |
| Enrollment | 154 (estimated) |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Drugs / interventions | CAR T, CAR-T |
| Locations | 1 site (New York, New York) |
| Status | Recruiting |
| Started | March 4, 2020 |
| Main results expected | March 4, 2027 |
| Study ends | March 4, 2027 |
| Registry record updated | April 7, 2026 |
| Trial ID | NCT04300998 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 60 or older with pathologically confirmed relapsed or refractory B‑cell lymphomas who are scheduled to receive a commercial CAR‑T product and who meet cohort-specific language and cognitive requirements are ideal candidates.
✕Probably not a fit
Patients who previously received any CAR‑T therapy, who have major active psychiatric or neurologic disorders, ongoing substance abuse, or who cannot attend visits at the New York site (or who fail cohort language/cognitive criteria) are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is an observational, single-center study enrolling patients aged 60 and older with relapsed or refractory B‑cell lymphomas who receive a commercial CAR‑T product at Memorial Sloan Kettering. Participants complete geriatric assessments including Activities of Daily Living, Instrumental ADLs, Timed Up and Go, cognition screening (MoCA), and the Geriatric Depression Scale at defined timepoints around CAR‑T treatment. No experimental treatments are given; investigators collect data to describe functional status, cognitive changes, and quality‑of‑life trajectories over time, with cohort-specific criteria for language and cognition. Patients with prior CAR‑T therapy or significant psychiatric, neurologic, or substance‑use histories are excluded in specified cohorts.
Why it matters
Potential benefit: If successful, results could help clinicians predict which older patients will tolerate CAR‑T best and tailor supportive care to preserve function and quality of life.
How similar studies have gone: Previous CAR‑T research has described safety and efficacy across age groups, but dedicated geriatric-focused quality‑of‑life and functional outcome data are limited, so this work builds on prior knowledge while addressing a gap.
Who can join: the full rules
Show full inclusion / exclusion criteria
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)
Where it's running
-
Memorial Sloan Kettering Cancer Center
New York, New York, United States Recruiting
Study contacts
- Principal investigator: Richard Lin, MD, PhD — Memorial Sloan Kettering Cancer Center
- Study coordinator: Richard Lin, MD, PhD
- Email: ABMTTrials@mskcc.org
- Phone: 646-608-2646
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.