Study of CAR-T Therapy in Older Patients

Recruiting

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

• Registration Number: NCT04300998
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-04
• Study First Submitted: 2020-03-05
• Study First Submitted QC: 2020-03-06
• Study First Posted: 2020-03-09
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-10
• Last Update Posted: 2025-06-13
• Primary Completion: 2026-03-04
• Study Completion: 2026-03-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 154

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of participants who complete all required assessment visits prior to disease progression or death	1 year	Participants who complete all assessment visits prior to disease progression or death will be considered as a success for a feasibility endpoint.

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States