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Intervenciones guiadas por evaluación geriátrica para acelerar la recuperación funcional después de la terapia CAR-T para pacientes de 60 años o más con linfoma no Hodgkin de células B o mieloma múltiple, estudio GOCART

20 de octubre de 2026 actualizado por: City of Hope Medical Center

Optimización guiada por evaluación geriátrica (G) (O) para acelerar la recuperación funcional después de la terapia con células T con receptor de antígeno quimérico (CAR-T) para pacientes de 60 años o más con linfoma no Hodgkin de células B o mieloma múltiple (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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

164

Fase

  • Fase 2

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Estados Unidos
    • California
      • Duarte, California, Estados Unidos, 91010
        • Reclutamiento
        • City of Hope Medical Center
        • Contacto:
          • Andrew S. Artz
          • Número de teléfono: 626-218-2405
          • Correo electrónico: aartz@coh.org
        • Investigador principal:
          • Andrew S. Artz
      • Irvine, California, Estados Unidos, 92618
        • Reclutamiento
        • City of Hope at Irvine Lennar
        • Contacto:
          • Andrew Artz, MD
          • Número de teléfono: 626-218-2405
          • Correo electrónico: aartz@coh.org
    • North Carolina
      • Winston-Salem, North Carolina, Estados Unidos, 27157
        • Reclutamiento
        • Wake Forest University, School of Medicine Dept. of Internal Medicine, Division of Hematology Oncology
        • Contacto:
    • Ohio
      • Columbus, Ohio, Estados Unidos, 43210
        • Reclutamiento
        • Ohio State University Medical Center Dept. of Internal Medicine, Division of Hematology
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

60 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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)

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Cuidados de apoyo
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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.
Otro: Questionnaire Administration

Ancillary studies

Otro: Cognitive Intervention

Receive delirium prevention education

Otro: Comprehensive Geriatric Assessment

Undergo geriatric assessment

Otro: Nutritional Intervention

Undergo nutritional optimization

Procedimiento: Physical Therapy

Undergo physical function optimization

Otros nombres:
  • PT
  • Procedimiento Fisiátrico
  • Procedimiento de Medicina Física
  • Fisioterapia
  • Procedimiento de fisioterapia
Comparador activo: Arm II (standard of care)

Patients undergo GA and receive standard of care throughout study.
Otro: Questionnaire Administration

Ancillary studies

Otro: Best Practice

Undergo standard of care

Otros nombres:
  • estándar de cuidado
  • terapia estándar

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Changes in Short Physical Performance Battery (SPPB)
Periodo de tiempo: From baseline to day 30 after chimeric antigen receptor T-cell (CAR-T) infusion

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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Successful in coordinating initial optimization
Periodo de tiempo: From enrollment to start of lymphodepletion

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
Periodo de tiempo: At 30 days post CAR-T infusion

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
Periodo de tiempo: At 30 days post CAR-T infusion

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
Periodo de tiempo: Up to 30 days post CAR-T infusion

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
Periodo de tiempo: Up to day 100

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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

City of Hope Medical Center

Colaboradores

National Cancer Institute (NCI)

Investigadores

  • Investigador principal: Andrew S Artz, City of Hope Medical Center

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

23 de junio de 2023

Finalización primaria (Estimado)

5 de septiembre de 2027

Finalización del estudio (Estimado)

5 de septiembre de 2027

Fechas de registro del estudio

Enviado por primera vez

11 de septiembre de 2023

Primero enviado que cumplió con los criterios de control de calidad

19 de septiembre de 2023

Publicado por primera vez (Actual)

25 de septiembre de 2023

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

22 de octubre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

20 de octubre de 2026

Última verificación

1 de octubre de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 22422
  • P30CA033572 (Subvención/contrato del NIH de EE. UU.)
  • 22422 (Otro identificador: City of Hope Medical Center)
  • NCI-2023-04359 (Identificador de registro: CTRP (Clinical Trial Reporting Program))

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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