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)

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.

Study Overview

• Status: Recruiting
• Conditions: Multiple Myeloma; B-Cell Non-Hodgkin Lymphoma
• Intervention / Treatment: Other: Questionnaire Administration; Other: Best Practice; Other: Cognitive Intervention; Other: Comprehensive Geriatric Assessment; Other: Nutritional Intervention; Procedure: Physical Therapy

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.

• Study Type: Interventional
• Enrollment (Estimated): 164
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Duarte, California, United States, 91010
      • Recruiting
      • City of Hope Medical Center
      • Contact: Andrew S. Artz; Phone Number: 626-218-2405; Email: aartz@coh.org
      • Principal Investigator: Andrew S. Artz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: Questionnaire Administration; Ancillary studies; 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 Names: PT; Physiatric Procedure; Physical Medicine Procedure; Physical Therapeutics; Physical Therapy Procedure; Physiotherapy; Physiotherapy Procedure
Active Comparator: Arm II (standard of care); Patients undergo GA and receive standard of care throughout study.	Other: Questionnaire Administration; Ancillary studies; Other: Best Practice; Undergo standard of care; Other Names: standard of care; standard therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Short Physical Performance Battery (SPPB)	T-test will be used to compare SPPB changes score between two arms at 30 days after CAR-T infusion.	From baseline to day 30 after chimeric antigen receptor T-cell (CAR-T) infusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful in coordinating initial optimization	A physical or virtual visit will be tabulated separately for functional optimization, delirium prevention and nutrition. Adherence will be deemed to have been met if >=70% or more comlete tri-modality optimization before lymphodepletion in the modified intent to treat population.	From enrollment to start of lymphodepletion
Frailty progression	Frailty progression will be defined as a score of 3 or more at T2 if T1 not frail (<3); if frail at T1 (score 3-5), any worsening of the score; a score of 5 at day 30 if baseline score already at the maximum frailty of 5.	At 30 days post CAR-T infusion
Cognitive impairment	Assessed using the Montreal Cognitive Assessment (MoCA). Cognitive impairment defined as MoCA score of < 23 or unable to complete the MoCA due to cognitive impairment. The proportion of patients with cognitive impairment at day 30, irrespective of baseline cognition, will be compared between the two arms using Chi-square test.	At 30 days post CAR-T infusion
Weight loss	Malnourishment will be measured using weight loss and dichotomized as > 5% weight loss from baseline to day +30. The proportion of patients with over 5% weight loss from T1 to T2 will be compared between the two arms using Chi-square test.	Up to 30 days post CAR-T infusion
CAR-T associated neurotoxicity	Assessed using American Society for Transplantation and Cellular Therapy consensus grading for cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome (ICANS). The time to neurotoxicity (days), the maximum grade (1-4) and the duration of neurotoxicity (days) will be recorded. The cumulative incidence of ICANS (percentages) will be compared between arms as well as the maximum grade (1-4), and duration of neurotoxicity (days).	Up to day 100

Collaborators and Investigators

• Sponsor: City of Hope Medical Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Andrew S Artz, City of Hope Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2023
• Primary Completion (Estimated): October 5, 2026
• Study Completion (Estimated): October 5, 2026

Study Registration Dates

• First Submitted: September 11, 2023
• First Submitted That Met QC Criteria: September 19, 2023
• First Posted (Actual): September 25, 2023

Study Record Updates

• Last Update Posted (Estimated): October 6, 2025
• Last Update Submitted That Met QC Criteria: October 2, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms, Plasma Cell; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Hemic and Lymphatic Diseases; Lymphoma, B-Cell; Multiple Myeloma; Health Services Administration; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Therapeutics; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Quality Indicators, Health Care; Population Characteristics; Rehabilitation; Health Status; Demography; Epidemiologic Measurements; Guidelines as Topic; Quality Assurance, Health Care; Standard of Care; Practice Guidelines as Topic; Geriatric Assessment; Physical Therapy Modalities
• Other Study ID Numbers: 22422 (Other Identifier: City of Hope Medical Center); P30CA033572 (U.S. NIH Grant/Contract); NCI-2023-04359 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No