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

NCT06052826 | Recruiting Phase 2 DMC

• 3 other identifiers: 22422NCI-2023-04359P30CA033572
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

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 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.

Conditions

B-Cell Non-Hodgkin Lymphoma; Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Successful in coordinating initial optimization

  From enrollment to start of lymphodepletion

• Frailty progression

  At 30 days post CAR-T infusion

• Cognitive impairment

  At 30 days post CAR-T infusion

• Weight loss

  Up to 30 days post CAR-T infusion

• CAR-T associated neurotoxicity

  Up to day 100

Study Arms (2)

Arm I (PT, cognitive education, nutrition education)

EXPERIMENTAL

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: Cognitive Intervention; Other: Comprehensive Geriatric Assessment; Other: Nutritional Intervention; Procedure: Physical Therapy; Other: Questionnaire Administration

Arm II (standard of care)

ACTIVE COMPARATOR

Patients undergo GA and receive standard of care throughout study.

Other: Best Practice; Other: Questionnaire Administration

Interventions

Best Practice OTHER

Undergo standard of care

Also known as: standard of care, standard therapy

Arm II (standard of care)

Cognitive Intervention OTHER

Receive delirium prevention education

Arm I (PT, cognitive education, nutrition education)

Comprehensive Geriatric Assessment OTHER

Undergo geriatric assessment

Arm I (PT, cognitive education, nutrition education)

Nutritional Intervention OTHER

Undergo nutritional optimization

Arm I (PT, cognitive education, nutrition education)

Physical Therapy PROCEDURE

Undergo physical function optimization

Also known as: Physiatric Procedure, Physical Medicine Procedure, Physical Therapeutics, Physical Therapy Procedure, Physiotherapy, Physiotherapy Procedure, PT

Arm I (PT, cognitive education, nutrition education)

Questionnaire Administration OTHER

Ancillary studies

Arm I (PT, cognitive education, nutrition education); Arm II (standard of care)

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

RECRUITING

MeSH Terms

Conditions

Lymphoma, B-Cell; Multiple Myeloma

Interventions

Practice Guidelines as Topic; Standard of Care; Geriatric Assessment; Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Status; Demography; Population Characteristics; Health Care Evaluation Mechanisms; Epidemiologic Measurements; Public Health; Environment and Public Health; Therapeutics; Rehabilitation

Study Officials

• Andrew S Artz

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2023
• First Posted: September 25, 2023
• Study Start: June 23, 2023
• Primary Completion (Estimated): October 5, 2026
• Study Completion (Estimated): October 5, 2026
• Last Updated: October 6, 2025

Record last verified: 2025-10

Locations

US (1)