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Идёт набор NCT07249528

A Study of Voice as a Way to Monitor for Side Effects in People Receiving CAR T-Cell Therapy

— Наблюдательное Non-hodgkin Lymphoma Multiple Myeloma

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: Audio Tasks.
Кому может быть актуально
Состояния в реестре: Non-hodgkin Lymphoma, Multiple Myeloma. Базовые параметры: от 18 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
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Официальное название

Voice as a Digital Biomarker of Neurotoxicity in CAR T-Cell Therapy

Обзор

The purpose of this study is to collect voice recordings and nervous system (neurologic) assessments from people with non-Hodgkin lymphoma (NHL) or multiple myeloma (MM) who are receiving standard treatment with CAR T-cell therapy. Researchers will study whether these voice recordings and assessments are a practical (feasible) way to monitor for immune effector cell-associated neurotoxicity syndrome (ICANS). Feasibility will be measured by tracking how many participants join the study and complete the assessments.

Вмешательства

  • Диагностический тест Audio Tasks
    Voice recordings will be collected at baseline (pre-infusion), twice daily from Day 0 through Day +10, and, if ICANS develops, twice daily until three days after clinical resolution. A final voice recording will also be performed on Day +30

Первичные конечные точки

  • Number of daily voice recordings collected [Срок оценки: 30 days after baseline]
  • Number of neurocognitive assessments collected [Срок оценки: 30 days after baseline]

Критерии участия

Критерии включения

  • Documentation of Disease

o Patients must have pathologically confirmed Diagnosed with non-Hodgkin lymphoma or multiple myeloma.

  • Definition of treatment and ability
  • Scheduled to receive an FDA-approved CAR-T product: Axi-cel, Liso-cel, Tisa-cel, Ide-cel, Cilta-cel, or Brexu-cel.
  • Ability to comply with twice daily voice recordings or daily neurologic assessments, as determined by the investigator.
  • Age ≥ 18
  • ECOG Performance Status of ≤ 2
  • Required
  • Perform twice daily voice recordings using a smartphone.
  • Undergo daily neurologic assessments (e.g., ICE score, tremor evaluation).
  • Smartphone ownership.
  • Sufficient English proficiency to complete structured voice tasks in the study application.
  • Comorbid Conditions
  • No pre-existing neurological conditions that significantly impair speech, including but not limited to severe dysarthria, expressive aphasia, or neurodegenerative disorders.
  • No history of significant speech or voice disorders, including laryngeal paralysis, severe dysphonia, or recent vocal cord surgery or radiation to the area.
  • No pathology affecting the vocal cords that could interfere with voice analysis, such as vocal cord paralysis, chronic laryngitis, vocal cord nodules, polyps, granulomas, or malignancies.
  • No severe hearing impairment that would interfere with voice assessments
  • Language o Proficiency in spoken English is required, without the need for native-level fluency. This ensures participants can accurately perform structured voice tasks, as the application and underlying acoustic models are currently validated only in English, despite the limitation in generalizability. Participants with language barriers that prevent reliabletask completion or data interpretation will be excluded.

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 · 8 центров
  • Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities) — Basking Ridge
  • Memorial Sloan Kettering Monmouth (Consent only) — Middletown
  • Memorial Sloan Kettering Bergen (Consent Only) — Montvale
  • Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities) — Commack
  • Memorial Sloan Kettering Westchester (Consent only) — Harrison
  • Weill Cornell Medical Center (Data Analysis Only) — New York
  • Memorial Sloan Kettering Cancer Center (All Protocol Activites) — New York
  • Memorial Sloan Kettering Nassau (Limited Protocol Activities) — Rockville Centre

Идентификаторы

NCT: NCT07249528 · 25-317

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗