Study in Patients With Relapsed/Refractory Primary Mediastinal Lymphoma Treated With Pembrolizumab or Nivolumab in Combination With Brentuximab Vedotin in a Real-life Context
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: Primary Mediastinal B Cell 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
- 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
Retrospective Observational Study in Patients With Relapsed / Refractory Primary Mediastinal Lymphoma Treated With Pembrolizumab or Nivolumab in Combination With Brentuximab Vedotin in a Real-life Context
Обзор
Observational, Non-Interventional, Retrospective, Multicenter Study Focusing on the Efficacy and Safety of Pembrolizumab Monotherapy and Nivolumab in Combination With Brentuximab Vedotin in Clinical Practice Patients With Primary Mediastinal B Cell Lymphoma Relapsed/Refractory
Подробное описание
Observational, non-interventional, retrospective, multicentre study focusing on the efficacy and safety of pembrolizumab as monotherapy and nivolumab in combination with brentuximab vedotin in daily clinical practice in patients with Primary Mediastinal B Cell Lymphoma Relapsed/Refractory. The study aims to retrospectively evaluate the efficacy in terms of overall response rate (ORR, sum of complete response rate \[CR\] and partial response rate \[PR\]) of pembrolizumab as a single agent and nivolumab in combination with brentuximab vedotin in patients with Primary Mediastinal B Cell Lymphoma Relapsed/RefractoryL treated in a real-life setting from November 2020 until November 2021.
Secondary objectives
* To assess efficacy, in terms of: * Duration of response (DoR) * Progression-free survival (PFS) * Overall survival (OS) * Disease-free survival (DFS) * Best response rate (achieved at any time during treatment) * To evaluate the safety and tolerability of pembrolizumab as a single agent and nivolumab in combination with brentuximab vedotin The study will include patients with Primary Mediastinal B Cell Lymphoma Relapsed/Refractory treated with pembrolizumab as a single agent and nivolumab in combination with brentuximab vedotin in a real-life setting from November 2020 until November 2021.
Первичные конечные точки
- overall response rate (ORR) [Срок оценки: at the end of treatment, through study completion, an average of 2 years]
Вторичные конечные точки (7)
- Duration of Response (DoR) [Срок оценки: through study completion, an average of 2 years]
- Progression Free Survival (PFS) [Срок оценки: through study completion, an average of 2 years]
- Overall Survival (OS) [Срок оценки: through study completion, an average of 2 years]
- Disease Free Survival (DFS) [Срок оценки: through study completion, an average of 2 years]
- Best response rate (BRR) [Срок оценки: through study completion, an average of 2 years]
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [Срок оценки: through study completion, an average of 2 years]
- Incidence of Treatment-Emergent Serious Adverse Events [Safety and Tolerability] [Срок оценки: through study completion, an average of 2 years]
Критерии участия
Критерии включения
- Histologically confirmed diagnosis of Primary Mediastinal B Cell Lymphoma Relapsed/Refractory patients who underwent pembrolizumab as a single agent and nivolumab in combination with brentuximab vedotin in a real-life context with till Novembre 2021
- Age ≥ 18 years at enrollment
- Signature of written informed consent (where applicable)
Критерии исключения
1\. Primary Mediastinal B Cell Lymphoma Relapsed/Refractory patients who underwent pembrolizumab as a single agent and nivolumab in combination with brentuximab vedotin in a clinical trial context.
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 · 3 центра
- IRCCS Azienda Ospedaliero - Universitaria di Bologna — Bologna
- Azienda Ospedaliera Universitaria- POLICLINICO BARI — Bari
- Fondazione IRCCS Istituto Nazionale dei Tumori — Milan
Идентификаторы
NCT: NCT06781450 · PRIMICI