Идёт набор NCT05326308

Zanubrutinib in Patients With Waldenström's Macroglobulinemia, Chronic Lymphocytic Leukemia, Marginal Zone Lymphoma and Follicular Lymphoma

— Наблюдательное Waldenström's Macroglobulinemia Chronic Lymphocytic Leukemia Marginal Zone Lymphoma Follicular Lymphoma

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: Zanubrutinib, Obinutuzumab.
Кому может быть актуально: Состояния в реестре: Waldenström's Macroglobulinemia, Chronic Lymphocytic Leukemia, Marginal Zone Lymphoma, Follicular Lymphoma. 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: Австрия, Германия
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

Zanubrutinib (Brukinsa®) in Patients With Waldenström's Macroglobulinemia (WM), Chronic Lymphocytic Leukemia (CLL), Marginal Zone Lymphoma (MZL) and Follicular Lymphoma (FL) - a Prospective Multicenter Observational Cohort Study

Обзор

The objective of this NIS is to evaluate medical resource utilization, where data is rare in all cohorts, patient's QoL and effectiveness of zanubrutinib treatment in adult patients with WM, CLL, MZL and FL in a real-world setting.

Подробное описание

ARIADNE will collect and analyze data of adult patients with WM, CLL, MZL or FL in need of treatment. The study will explore the medical resource utilization during therapy with zanubrutinib (Brukinsa®). Further aims are to assess effectiveness, safety and tolerability of the treatment as well as treatment satisfaction and biomarkers. These data will be supplemented by the assessment of patient-reported outcomes (PROs)/ health-related quality of life (QoL).

Since treatment options for MW, CLL, MZL or FL are limited and the most important factor is to keep or improve QoL of the patients, there is an urge for real-world clinical data of patients treated with zanubrutinib, especially focusing on patients already treated upfront with a BTK inhibitor, older patients and patients with comorbidities.

Вмешательства

Препарат Zanubrutinib
according to the Summary of Product Characteristics (SmPC).
Препарат Obinutuzumab
according to the Summary of Product Characteristics (SmPC).

Первичные конечные точки

Medical resource utilization [Срок оценки: During zanubrutinib treatment, up to 6.3 years]

Вторичные конечные точки (12)

Global health-related quality of life (QoL) collected via EORTC QLQ-C30 during course of treatment and follow-up [Срок оценки: During zanubrutinib treatment and follow-up, up to 6.3 years]
Global health-related quality of life (QoL) collected via EQ-5D-5L during course of treatment and follow-up [Срок оценки: During zanubrutinib treatment and follow-up, up to 6.3 years]
Incidence of (serious) adverse events ((S)AEs) [Срок оценки: Start of zanubrutinib treatment until 30 days after end of zanubrutinib treatment]
Incidence of (serious) adverse drug reactions ((S)ADRs) [Срок оценки: Start of zanubrutinib treatment until end of study, up to 6.3 years]
Incidence of adverse events of special interest (AESIs) [Срок оценки: Start of zanubrutinib treatment until 30 days after end of zanubrutinib treatment]
Time to AESIs [Срок оценки: Start of zanubrutinib treatment until 30 days after end of zanubrutinib treatment]
Time to neutropenia [Срок оценки: Start of zanubrutinib treatment until 30 days after end of zanubrutinib treatment]
Rate of neutropenia grade ≥3 [Срок оценки: Start of zanubrutinib treatment until 30 days after end of zanubrutinib treatment]
Proportion of patients with complete response (CR) or very good partial response (VGPR) (best reported response) [Срок оценки: During zanubrutinib treatment, up to 6.3 years]
In the WM cohort only: Major response rate (MRR) [Срок оценки: During zanubrutinib treatment, up to 6.3 years]
In the WM cohort only: Best response [Срок оценки: During zanubrutinib treatment, up to 6.3 years]
In the WM cohort only: IgM levels [Срок оценки: During zanubrutinib treatment, up to 6.3 years]

Критерии участия

Критерии включения

Waldenström's macroglobulinemia (all treatment lines) OR
Chronic lymphocytic leukemia (all treatment lines) OR
Marginal zone lymphoma (≥2 treatment line and at least one anti-CD20 antibody-based previous therapy)
Follicular lymphoma (≥3 treatment line)
Signed and dated informed consent form
Treatment with zanubrutinib according to current SmPC for WM, CLL and MZL
Treatment with zanubrutinib + obinutuzumab for FL according to current SmPC
Treatment decision before inclusion into this non-interventional study
Age ≥18 years.

Критерии исключения

Contraindications according to SmPC for patients with WM, CLL, MZL or FL
Participation in an interventional clinical trial during zanubrutinib treatment.

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

Здоровые добровольцы: Нет