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Идёт набор NCT05557695

Observational Study of Acalabrutinib in Patients With Chronic Lymphocytic Leukaemia in the United Kingdom

— Наблюдательное Chronic Lymphocytic Leukemia, CLL

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: Acalabrutinib.
Кому может быть актуально
Состояния в реестре: Chronic Lymphocytic Leukemia, CLL. Базовые параметры: 18 лет — 130 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
Великобритания
Следующий шаг
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Официальное название

A Non-interventional, Observational Cohort Study of Chronic Lymphocytic Leukaemia Patients Treated With Acalabrutinib in the First-line Setting Through the UK Early Access Programme: Early Access Programme Outcomes In aCalabrutinib (EPIC).

Обзор

This is a retrospective observational research study to describe the characteristics and real-world clinical outcomes of patients with chronic lymphocytic leukaemia receiving acalabrutinib in the United Kingdom (the EPIC study). Physicians treating chronic lymphocytic leukaemia patients with acalabrutinib, where the patients started treatment as part of the acalabrutinib Early Access Programme (EAP), will be invited to recruit patients. Clinical data will be extracted from the patients' clinical records in line with local laws. Data from this study will provide UK-specific real-world data on patients who were started on acalabrutinib as part of the UK acalabrutinib EAP.

Подробное описание

1. Primary Objectives:

a. To estimate real-world progression-free survival in patients with CLL who received acalabrutinib in the first-line. 2. Secondary Objectives:

1. To estimate real-world overall survival in patients with CLL who received acalabrutinib in the first-line. 2. To describe real-world response rate to acalabrutinib in patients with CLL who received acalabrutinib in the first-line. 3. To describe the healthcare resource utilisation in patients with CLL who received acalabrutinib in the first-line. 4. To describe post-progression treatment patterns in patients with CLL who progressed from first-line acalabrutinib. 5. To describe real-world clinical progression free survival in patients with CLL who received acalabrutinib in the first-line and progressed during acalabrutinib treatment. 6. To describe acalabrutinib treatment patterns in patients with CLL who received acalabrutinib in the first-line. 7. To describe baseline clinical and demographic characteristics in patients with CLL who received acalabrutinib in the first-line.

Вмешательства

  • Препарат Acalabrutinib
    Acalabrutinib

Первичные конечные точки

  • Real-world progression free survival (rwPFS) [Срок оценки: 12 months]
  • Real-world progression free survival (rwPFS) [Срок оценки: 24 months]
  • Real-world progression free survival (rwPFS) [Срок оценки: 36 months]
  • Real-world progression free survival (rwPFS) [Срок оценки: 48 months]
  • Real-world progression free survival (rwPFS) [Срок оценки: 60 months]
Вторичные конечные точки (12)
  • Real-world overall survival (rwOS) [Срок оценки: 12 months]
  • Real-world overall survival (rwOS) [Срок оценки: 24 months]
  • Real-world overall survival (rwOS) [Срок оценки: 36 months]
  • Real-world overall survival (rwOS) [Срок оценки: 48 months]
  • Real-world overall survival (rwOS) [Срок оценки: 60 months]
  • Real-world response rate (rwRR) [Срок оценки: 12 months]
  • Real-world response rate (rwRR) [Срок оценки: 24 months]
  • Real-world response rate (rwRR) [Срок оценки: 36 months]
  • Real-world response rate (rwRR) [Срок оценки: 48 months]
  • Real-world response rate (rwRR) [Срок оценки: 60 months]
  • Real-world clinical progression free survival 2 (rwPFS2) [Срок оценки: 12 months]
  • Real-world clinical progression free survival 2 (rwPFS2) [Срок оценки: 24 months]

Критерии участия

The study population will include treatment-naïve patients with chronic lymphocytic lymphoma (CLL)\* who meet the following inclusion criteria:

  • Treatment-naïve CLL patients who were initiated on acalabrutinib as part of the UK Early Access Programme
  • Received their first dose of acalabrutinib between 1 April 2020 and 1 April 2021
  • Patients aged ≥18 years old
  • Note: patients later found to have small lymphocytic lymphoma (SLL) may also be included in the EAP.

Критерии исключения

\- None listed in study protocol

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Великобритания · 29 центров
  • Research Site — Aylesbury
  • Research Site — Bath
  • Research Site — Birmingham
  • Research Site — Bournemouth
  • Research Site — Cardiff
  • Research Site — Cornwall
  • Research Site — Dartford
  • Research Site — Derby
  • … и ещё 21 центр

Идентификаторы

NCT: NCT05557695 · D8220R00033

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗