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Идёт набор NCT07602088

A Real-world Study of Ibrutinib and Venetoclax (I+V) First-Line Treatment Given for Fixed-duration of Time in Participants With Chronic Lymphocytic Leukemia

— Наблюдательное Leukemia, Lymphocytic, Chronic, B-Cell

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Leukemia, Lymphocytic, Chronic, B-Cell. 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
Румыния
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

Prospective Cohort Study With Fixed-Duration Ibrutinib + Venetoclax (I+V) First-Line Treatment in Patients With Chronic Lymphocytic Leukemia in a Real-World Setting

Обзор

The purpose of this study is to see how well Ibrutinib and Venetoclax (I+V) treatment works (effectiveness) for participants with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) when it is used in routine, everyday medical care.

Первичные конечные точки

  • Overall Response Rate (ORR) [Срок оценки: Up to approximately Week 60]
Вторичные конечные точки (12)
  • Number of Participants with Factors Affecting the Physician Treatment Decision Using the Physician's Treatment Decision Questionnaire [Срок оценки: At baseline]
  • Number of Participants with Factors Affecting Participant's Decision to Accept or Continue with the Proposed Treatment Using the Physician's Treatment Decision Questionnaire [Срок оценки: At baseline]
  • Overall Response Rate (ORR) By the End of Treatment Cycles [Срок оценки: Up to approximately Week 48]
  • Duration of response (DoR) [Срок оценки: Up to approximately Week 60]
  • Progression-free survival (PFS) [Срок оценки: Up to approximately 4 years]
  • Overall survival (OS) [Срок оценки: Up to approximately 4 years]
  • Time on treatment (TOT) [Срок оценки: Up to approximately Week 60]
  • Time to Treatment Discontinuation (TTD) [Срок оценки: Up to approximately Week 60]
  • Time to Next Treatment (TTNT) [Срок оценки: Up to approximately Week 60]
  • Change from Baseline in Health-Related Quality of Life as Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Chronic lymphocytic leukemia 17 (EORTC QLQ-CLL17) [Срок оценки: From Baseline up to approximately 4 years]
  • Number of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and Special Situations [Срок оценки: Up to approximately 4 years]
  • Number of Participants with Tumor Lysis Risk [Срок оценки: At Baseline and After 12 Weeks]

Критерии участия

Критерии включения

  • Has a confirmed diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) requiring treatment according to international workshop on chronic lymphocytic leukemia (iwCLL) 2018 guidelines
  • Intented for the treatment with fixed-duration ibrutinib plus venetoclax treatment (I+V) according to the approved indication. Decision to start I+V treatment must have been taken before and independently of participant's inclusion in the study
  • Participant must sign an informed consent form (ICF) allowing source data verification in accordance with local requirements
  • Is able to read, understand, and complete the PRO instruments in local language and comply with completion of all patient-reported outcome (PRO) instruments

Критерии исключения

  • Has a history of CLL/SLL treatment
  • Has received an investigational medicinal product (including investigational vaccines) or used an invasive investigational medical device within 30 days before the start of the study or the first data collection time point
  • Is currently enrolled or plans to participate in an interventional clinical study (participation in a non-Janssen sponsored non-interventional study or registry is allowed)
  • Falls under any restrictions or limitations preventing treatment with I+V as per the current approved label of ibrutinib or venetoclax in Romania

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Румыния · 1 центр
  • Spitalul Universitar de Urgenta Bucuresti — Bucharest

Идентификаторы

NCT: NCT07602088 · 54179060CLL4039

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗