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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age60+
SponsorCity of Hope Medical Center

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Best Practice
  • Cognitive Intervention
  • Comprehensive Geriatric Assessment
  • Nutritional Intervention
  • Physical Therapy
  • Questionnaire Administration

Treatment groups

164 Participants
are divided into 2 treatment groups

Sponsors and collaborators

City of Hope Medical Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator