Recruiting
Phase 2

Geriatric Assessment

Sponsor:

City of Hope Medical Center

Code:

NCT06052826

Conditions

B-Cell Non-Hodgkin Lymphoma

Multiple Myeloma

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Interventions

Best Practice

Cognitive Intervention

Comprehensive Geriatric Assessment

Nutritional Intervention

Physical Therapy

Study Details

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

Study ID

NCT06052826

Start date

Jun 23, 2023

Status verified date

Oct, 2025

Completion date

Oct 5, 2026

Anticipated

Primary completion date

Oct 5, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

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 Design

Enrollment

164 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

active comparator: Arm II (standard of care)

Patients undergo GA and receive standard of care throughout study.

Interventions

Best Practice

Undergo standard of care

Cognitive Intervention

Receive delirium prevention education

Comprehensive Geriatric Assessment

Undergo geriatric assessment

Nutritional Intervention

Undergo nutritional optimization

Physical Therapy

Undergo physical function optimization

Questionnaire Administration

Ancillary studies

Primary outcome measure

  • Changes in Short Physical Performance Battery (SPPB) [ Time Frame: From baseline to day 30 after chimeric antigen receptor T-cell (CAR-T) infusion ]

Central Contacts and Locations

Locations

City of Hope Medical Center

Recruiting

Duarte, California, United States, 91010

Contacts

Andrew S. Artz

626-218-2405aartz@coh.org

Principal Investigator:

Andrew S. Artz

More Information

Sponsor

City of Hope Medical Center

Last update posted

Oct 6, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by City of Hope Medical Center on 2025-10-06.