Geriatric assessment to improve recovery after CAR-T therapy for older patients with blood cancers
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)
This study is testing if personalized support and therapy can help older patients with blood cancers recover better after receiving CAR-T treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 164 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | City of Hope Medical Center Academic / other |
| Drugs / interventions | CAR-T, chimeric antigen receptor, chemotherapy |
| Locations | 1 site (Duarte, California) |
| Trial ID | NCT06052826 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of geriatric assessment (GA) guided interventions aimed at enhancing functional recovery in patients aged 60 and older undergoing CAR-T therapy for B-cell non-Hodgkin lymphoma or multiple myeloma. Participants will be randomized into two groups: one receiving standard care and the other receiving GA-informed interventions, which include physical therapy and cognitive support. The study will assess various outcomes, including physical function, cognitive impairment, and quality of life at multiple time points post-treatment. The goal is to identify and mitigate potential side effects of CAR-T therapy in older adults through tailored interventions.
Who should consider this trial
Good fit: Ideal candidates are patients aged 60 and older who are scheduled to receive FDA-approved CAR-T therapy for multiple myeloma or B-cell non-Hodgkin lymphoma.
Not a fit: Patients who have previously undergone CAR-T therapy or have conditions that contraindicate participation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve recovery and quality of life for older patients undergoing CAR-T therapy.
How similar studies have performed: While geriatric assessments have been utilized in various contexts, this specific approach in conjunction with CAR-T therapy for older adults is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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)
Where this trial is running
Duarte, California
- City of Hope Medical Center — Duarte, California, United States (Recruiting)
Study contacts
- Principal investigator: Andrew S Artz — City of Hope Medical Center
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.