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Набор скоро начнётся NCT07463781

Neurocognitive Assessment in Adults Undergoing CD19 Targeted CAR-T Cell Therapy

— Наблюдательное Diffuse Large B Cell Lymphoma (DLBCL) High Grade B Cell Lymphoma Primary Mediastinal B-cell Lymphoma (PMBCL)

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: Chimeric Antigen Receptor T-cells (CAR-T) therapy.
Кому может быть актуально
Состояния в реестре: Diffuse Large B Cell Lymphoma (DLBCL), High Grade B Cell Lymphoma, Primary Mediastinal B-cell Lymphoma (PMBCL). 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
Италия
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

Neurocognitive Assessment in Adults Undergoing CD19 Targeted CAR-T Cell Therapy: a Multicenter Observational Prospective Study

Обзор

This is an observational, multicenter, prospective cohort study including patients treated with CAR-T in Italian centers. Patients eligible for enrollment in the study will be consecutively included in Italian FIL centers. A longitudinal survey will be carried out by collecting patients' data before starting CAR-T (T0) and after 6 (T1), 12 (T2) and 24 (T3) months after CAR-T infusion.

Вмешательства

  • Другое Chimeric Antigen Receptor T-cells (CAR-T) therapy
    Patients will be treated with CAR-T cell product as per routine clinical practice.

Первичные конечные точки

  • Self-assessed neurocognitive performance [Срок оценки: The endpoint wil be evaluated at screening (before starting CAR-T therapy), at 6, 12 and 24 months after CAR-T infusion (from the beginning of the study at least 24 months after CAR-T infusion)]
  • Neurocognitive performance evaluation: Cognitive Status - Mini-Mental State Examination (MMSE) [Срок оценки: The endpoint wil be evaluated at screening (before starting CAR-T therapy), at 6, 12 and 24 months after CAR-T infusion (from the beginning of the study at least 24 months after CAR-T infusion)]
  • Quality of Life (QoL) [Срок оценки: The endpoint wil be evaluated at screening (before starting CAR-T therapy), at 6, 12 and 24 months after CAR-T infusion (from the beginning of the study at least 24 months after CAR-T infusion)]
  • Psychological status [Срок оценки: The endpoint wil be evaluated at screening (before starting CAR-T therapy), at 6, 12 and 24 months after CAR-T infusion (from the beginning of the study at least 24 months after CAR-T infusion)]
  • Resilience [Срок оценки: The endpoint wil be evaluated at screening (before starting CAR-T therapy), at 6, 12 and 24 months after CAR-T infusion (from the beginning of the study at least 24 months after CAR-T infusion)]
  • Adverse events [Срок оценки: The endpoint wil be evaluated at 6, 12 and 24 months after CAR-T infusion (from the beginning of the study at least 24 months after CAR-T infusion)]
  • Treatment characteristics: Previous Central Nervous System Prophylaxis [Срок оценки: The endpoint wil be evaluated at screening (before starting CAR-T therapy)]
  • Overall Survival (OS) [Срок оценки: The endpoint will be evaluated from the beginning to the end of the study (at least 24 months after CAR-T infusion)]
  • Neurocognitive performance evaluation: Praxic Abilities - Rey-Osterrieth Complex Figure Test (Copy Condition) [Срок оценки: The endpoint wil be evaluated at screening (before starting CAR-T therapy), at 6, 12 and 24 months after CAR-T infusion (from the beginning of the study at least 24 months after CAR-T infusion)]
  • Neurocognitive performance evaluation: Verbal Memory - Rey Auditory Verbal Learning Test (Word List 3 Recall) [Срок оценки: The endpoint wil be evaluated at screening (before starting CAR-T therapy), at 6, 12 and 24 months after CAR-T infusion (from the beginning of the study at least 24 months after CAR-T infusion)]

Критерии участия

Критерии включения

  • Patients with previous diagnosis of Diffuse Large B Cell Lymphoma or High- Grade B Cell Lymphoma (DLBCL/HGBL), arising de novo or transformed from a previous indolent histotype (transformed Follicular Lymphoma or transformed Marginal Zone Lymphoma), Primary Mediastinal B Cell Lymphoma (PMBCL).
  • Patients undergoing CD19-targeted CAR-T cell salvage therapy for relapsed/refractory disease according to AIFA inclusion criteria.
  • Age over 18-years-old at the time of lymphoma diagnosis.

Критерии исключения

  • Patient with histological diagnosis of mantle cell lymphoma (MCL) or acute lymphoblastic leukemia (ALL)
  • Patients with CNS disease localization.
  • Patients that received brain/neuroaxis radiotherapy.
  • Pre-existing severe psychiatric or neurologic comorbidities influencing neurocognitive assessment.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Италия · 8 центров
  • SCDU Ematologia - AOU SS. Antonio e Biagio e Cesare Arrigo di Alessandria — Alessandria
  • Clinica di Ematologia, AOU Ospedali Riuniti — Ancona
  • USD-TMO Adulti - ASST Spedali Civili di Brescia — Brescia
  • Divisione di Ematologia - A.O. Ospedali Riuniti Villa Sofia-Cervello — Palermo
  • Ematologia - Grande Ospedale Metropolitano Bianchi Melacrino Morelli — Reggio Calabria
  • Ematologia - Università Cattolica S. Cuore — Roma
  • SC Ematologia - Ospedale "S.G. Moscati" — Taranto
  • SOC Clinica Ematologica - Azienda Sanitaria Universitaria Friuli Centrale (ASU FC) — Udine

Идентификаторы

NCT: NCT07463781 · FIL_NEURO_CAR-T

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗