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
Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Other
Study Type: Observational
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Healthy Volunteers: f
View:
• 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)
Locations
United States
New York
Memorial Sloan Kettering Cancer Center
RECRUITING
New York
Contact Information
Primary
Richard Lin, MD, PhD
ABMTTrials@mskcc.org
646-608-2646
Backup
Sergio Giralt, MD
ABMTTrials@mskcc.org
Time Frame
Start Date: 2020-03-04
Estimated Completion Date: 2026-03-04
Participants
Target number of participants: 154
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Memorial Sloan Kettering Cancer Center