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

Официальное название

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)

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Best Practice
  Undergo standard of care
• Другое Cognitive Intervention
  Receive delirium prevention education
• Другое Comprehensive Geriatric Assessment
  Undergo geriatric assessment
• Другое Nutritional Intervention
  Undergo nutritional optimization
• Процедура Physical Therapy
  Undergo physical function optimization
• Другое Questionnaire Administration
  Ancillary studies

Первичные конечные точки

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

Вторичные конечные точки (5)

• Successful in coordinating initial optimization [Срок оценки: From enrollment to start of lymphodepletion]
• Frailty progression [Срок оценки: At 30 days post CAR-T infusion]
• Cognitive impairment [Срок оценки: At 30 days post CAR-T infusion]
• Weight loss [Срок оценки: Up to 30 days post CAR-T infusion]
• CAR-T associated neurotoxicity [Срок оценки: Up to day 100]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• City of Hope Medical Center — Duarte

Идентификаторы

NCT: NCT06052826 · 22422 · NCI-2023-04359 · 22422 · P30CA033572

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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