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Идёт набор NCT04300998

Study of CAR-T Therapy in Older Patients

— Наблюдательное Lymphoma Refractory B-Cell Lymphoma Lymphoma, B-Cell DLBCL NOS

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Activities of Daily Living/ADLs, Instrumental Activity of Daily Living, Timed Up and Go, Cognition.
Кому может быть актуально
Состояния в реестре: Lymphoma, Refractory B-Cell Lymphoma, Lymphoma, B-Cell, DLBCL NOS. Базовые параметры: от 60 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Observational Study of Commercial Chimeric Antigen Receptor T-cell (CAR T) Therapy in Older Patients With Hematologic Malignancies and With an Embedded Pilot Study of Longitudinal Geriatric and Neurocognitive Evaluation

Обзор

This study is being done to find out how older patients respond to CAR-T cell therapy and how the treatment affects their quality of life. This is a quality of life study and participating in the study does not involve receiving any treatment, other than the standard treatment for participants' disease.

Вмешательства

  • Поведенческое Activities of Daily Living/ADLs
    7 activities: bathing, dressing, grooming, feeding, walking inside the home, walking outside the home, and bladder and bowel control. Participants get 2 points for each activity that is not limited at all, 1 point for limited a little, and 0 points for limited a lot. Total ADL score ranges from 0 to 14
  • Поведенческое Instrumental Activity of Daily Living
    8 activities: telephone use, doing laundry, shopping, preparing meals, doing housework, handling own medications, handling money and finances, and transportation to visit one's doctor. Participants get 2 points for each activity that can be done without help, 1 point for needing some help, and 0 point for being unable to do. Total iADL score ranges from 0 to16.
  • Поведенческое Timed Up and Go
    Participants are asked to get up from the chair, walk 10 feet, turn, and walk back to the char (\<10 seconds, 10-20 seconds, \>20 seconds)
  • Поведенческое Cognition
    Mini-Cognition test: CDT and 3-word recall
  • Поведенческое Geriatric Depression Scale
    Four yes/no questions regarding patient's psychological status. Score ranges from 0 to 4, and a score of \>/=1 is usually indicative of depression.
  • Поведенческое Social Support
    Four 5-point Likert scale questions addressing 4 domains of social support: emotional/ informational, tangible, affectionate, and positive social interaction. Score for each item ranges from 1 to 5, and total score ranges from 4 to 20. A higher score means better social support.
  • Поведенческое Brief Test of Attention
    assess selective auditory attention.
  • Поведенческое Trail Making Test
    Assesses visual scanning, graphomotor speed, and set shifting.
  • Поведенческое Controlled Oral Word Association Test
    A timed test of verbal fluency
  • Поведенческое Hopkins Verbal Learning Test-Revised
    The HVLT-R is a test of verbal learning and recall. Scores obtained are the total number of words: 1) recalled over three trials; 2)recalled after a delay; 3) correctly recognized.

Первичные конечные точки

  • Number of participants who complete all required assessment visits prior to disease progression or death [Срок оценки: 1 year]

Критерии участия

Критерии включения

  • are ≥60 years old (all cohorts)
  • have pathologically confirmed, relapsed refractory lymphoid malignancy or plasma cell disorder receiving a commercial CAR T-cell product (all cohorts)
  • able to speak and understand English (cohort 1 and 4 only)
  • have a MoCA score of less than 26 out of 30 during the GA visit by a geriatrician prior to CAR T-cell treatment (cohort 4 only)

Критерии исключения

  • Any prior commercial or investigational CAR T therapy (all cohorts)
  • Current diagnosis of major Axis I psychiatric disorder (DSM-IV), major depression, bipolar disorder, or schizophrenia, as per medical records or patient report (cohort 1 only)
  • History of a neurological disorder, neurodegenerative disease, or traumatic brain injury with loss of consciousness (>60 minutes), as per medical records or patient report (cohort 1 only)
  • Current ongoing substance abuse and/or history of substance abuse, as per medical records or patient report (cohort 1 only)
  • History of CNS disease (cohort 4 only)

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 1 центр
  • Memorial Sloan Kettering Cancer Center — New York

Идентификаторы

NCT: NCT04300998 · 19-452

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗