Geriatric (G) Assessment Guided Optimization (O) to Accelerate Functional Recovery After Chimeric Antigen Receptor T-Cell (CAR-T) Therapy for Patients 60 Years and Older With B-Cell Non-Hodgkin Lymphoma or Multiple Myeloma (GOCART)

Status: Recruiting
Location: See location...
Intervention Type: Other, Procedure
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This clinical trial compares the effectiveness of geriatric assessment (GA) guided interventions to accelerate functional recovery after chimeric antigen receptor T-cell (CAR-T) therapy compared to standard of care (SOC) in patients 60 years and older with B-cell non-Hodgkin lymphoma (NHL) or multiple myeloma (MM). A large number of patients diagnosed with cancer are over the age of 60, yet most cancer treatments are developed for younger patients. Therefore, older patients may be less likely to be offered stronger treatments, such as CAR-T therapy, due to possible side effects. Geriatric assessment is a multi-dimensional health assessment tool combining patient reported and objective measures covering physical function, mental processes (cognitive), and nutrition. Pre-treatment assessments may identify weaknesses in older adults and may guide interventions for physical therapy, cognitive changes and nutrition to decrease CAR-T therapy side effects and improve care in older adults with NHL or MM.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Healthy Volunteers: f
View:

• Ability to provide informed consent

• Patient's physician must agree for patient participation. A physician may elect to provide blanket agreement for participation of any eligible CAR-T patient under their care

• Ability to read English, or Spanish. Other languages will be acceptable with site principal investigator (PI) agreement if surveys are available and language does not preclude completing study procedures

• Age: \>= 60 years at the time of enrollment

• Scheduled to receive an Food and Drug Administration (FDA)-approved CAR-T for treatment of multiple myeloma or B-cell non- Hodgkin lymphoma

• Willing and able to complete study requirements

• Patients expect to be able to participate at least once before lymphodepletion with trimodality optimization visits

Locations
United States
California
City of Hope Medical Center
RECRUITING
Duarte
Time Frame
Start Date: 2023-06-23
Estimated Completion Date: 2026-10-05
Participants
Target number of participants: 164
Treatments
Experimental: Arm I (PT, cognitive education, nutrition education)
Patients undergo GA before lymphodepleting chemotherapy and recommendations based on assessment results communicated to treating physicians. Patients receive PT and delirium prevention education prior to lymphodepletion, at least once before CAR-T therapy, at least 2 times a week while inpatient, and at least once every other week outpatient up to day 30. Additionally, patients receive personalized nutritional guidance from a registered dietician prior to lymphodepletion, prior to CAR-T therapy and at least once a week up to day 30.
Active_comparator: Arm II (standard of care)
Patients undergo GA and receive standard of care throughout study.
Sponsors
Leads: City of Hope Medical Center
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov

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