Status:
RECRUITING
Geriatric Assessment Guided Interventions to Accelerate Functional Recovery After CAR-T Therapy for Patients 60 Years and Older With B-cell Non-Hodgkin Lymphoma or Multiple Myeloma, GOCART Study
Lead Sponsor:
City of Hope Medical Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
B-Cell Non-Hodgkin Lymphoma
Multiple Myeloma
Eligibility:
All Genders
60+ years
Phase:
PHASE2
Brief 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 st...
Detailed Description
PRIMARY OBJECTIVE: I. Evaluate the effects of a GA-informed multi-disciplinary intervention in attenuating physical function decline among older patients receiving CAR-T therapy at day +30 post-CAR-T...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Prior CAR-T therapy
- Any condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
- Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
Key Trial Info
Start Date :
June 23 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 5 2026
Estimated Enrollment :
164 Patients enrolled
Trial Details
Trial ID
NCT06052826
Start Date
June 23 2023
End Date
October 5 2026
Last Update
October 6 2025
Active Locations (1)
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1
City of Hope Medical Center
Duarte, California, United States, 91010