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

Last updated: September 20, 2024
Sponsor: City of Hope Medical Center
Overall Status: Active - Recruiting

Phase

2

Condition

Multiple Myeloma

Lymphoma, B-cell

Lymphoma

Treatment

Cognitive Intervention

Comprehensive Geriatric Assessment

Nutritional Intervention

Clinical Study ID

NCT06052826
22422
NCI-2023-04359
P30CA033572
22422
  • Ages > 60
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Ability to provide informed consent

  • Patient's physician must agree for patient participation. A physician may elect toprovide blanket agreement for participation of any eligible CAR-T patient undertheir care

  • Ability to read English, or Spanish. Other languages will be acceptable with siteprincipal investigator (PI) agreement if surveys are available and language does notpreclude completing study procedures

  • Age: >= 60 years at the time of enrollment

  • Scheduled to receive an Food and Drug Administration (FDA)-approved CAR-T fortreatment 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 withtrimodality optimization visits

Exclusion

Exclusion Criteria:

  • Prior CAR-T therapy

  • Any condition that would, in the Investigator's judgment, contraindicate thepatient's participation in the clinical study due to safety concerns with clinicalstudy procedures

  • Prospective participants who, in the opinion of the investigator, may not be able tocomply with all study procedures (including compliance issues related tofeasibility/logistics)

Study Design

Total Participants: 164
Treatment Group(s): 6
Primary Treatment: Cognitive Intervention
Phase: 2
Study Start date:
June 23, 2023
Estimated Completion Date:
October 05, 2026

Study 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.

Connect with a study center

  • City of Hope Medical Center

    Duarte, California 91010
    United States

    Active - Recruiting

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