NCT06052826

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

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 164 (estimated)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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.

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 infusion. SECONDARY OBJECTIVES: I. Determine success in coordinating trimodality optimization before lymphodepletion. II. Compare rates of geriatric syndromes of frailty, cognitive impairment and malnourishment in SOC and GA-intervention cohorts at 30 days post-CAR-T infusion. III. Evaluate rates and duration of CAR-T related neurotoxicity in SOC and GA-intervention groups. EXPLORATORY OBJECTIVES: I. Quantify trimodality optimization intensity throughout treatment course. II. Compare longitudinal trajectory of Short Physical Performance Battery (SPPB), frailty, cognitive impairment and malnourishment between the two arms, at day +100 post-CAR-T infusion. III. Evaluate quality of life trajectories using the Patient Reported Outcomes Measurement Information System (PROMIS) Global Health Scale at baseline and days +30 and +100 in both cohorts. IV. Incidence of intensive care unit (ICU) admissions by day 100. V. Overall survival, response rate and progression-free survival through one year. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients undergo GA before lymphodepleting chemotherapy and recommendations based on assessment results communicated to treating physicians. Patients receive physical therapy (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. ARM II: Patients undergo GA and receive standard of care throughout study. After completion of study treatment, patients are followed up at day 100 and then up to 1 year.

Conditions

• B-Cell Non-Hodgkin Lymphoma
• Multiple Myeloma

Interventions

Type	Name	Description
OTHER	Best Practice	Undergo standard of care
OTHER	Cognitive Intervention	Receive delirium prevention education
OTHER	Comprehensive Geriatric Assessment	Undergo geriatric assessment
OTHER	Nutritional Intervention	Undergo nutritional optimization
PROCEDURE	Physical Therapy	Undergo physical function optimization
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2023-06-23
• Primary completion: 2026-10-05
• Completion: 2026-10-05
• First posted: 2023-09-25
• Last updated: 2025-10-06

Locations

1 site across 1 country: United States