Systemic Therapies in the Treatment of Cutaneous T-cell 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
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Cutaneous T Cell Lymphoma, Cutaneous T-Cell Lymphoma/Mycosis Fungoides, Cutaneous T-Cell Lymphoma/Sezary Syndrome. 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
Systemic Therapies in the Treatment of Cutaneous T-cell Lymphoma: an Observational Retrospective Multicenter Study
Обзор
The study is designed to describe the different approaches of systemic therapies for the treatment of Cutaneous T-cell Lymphoma in real world setting.
Подробное описание
The treatment of Mycosis Fungoides (MF)/Sézary Syndrome (SS) is based on a multimodal approach through the involvement of different specialists including hematologists, dermatologists, and radiation therapists. The approach to the treatment combines different skin directed and systemic therapies (such as chemotherapies, immunomodulating agents, immunotherapies).
Although there are several well recognized therapies for the treatment of MF/SS, curative therapies are still needed. In this scenario, effective treatments that provide long term responses and disease control are still lacking. Also, International guidelines (EORTC 2017, ESMO 2018, BAD2018, NCCN) report treatment options for the different stages without recommendations of any order due to lack of evidence from clinical trials.
This study is designed to analyze the different approaches of systemic therapies for the treatment of Cutaneous T-cell Lymphoma in real world setting.
Первичные конечные точки
- To evaluate the different systemic treatment approaches in real life settings in patients with CTCL. [Срок оценки: The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)]
- To evaluate the different systemic treatment approaches in real life settings in patients with CTCL. [Срок оценки: The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)]
- To evaluate the different systemic treatment approaches in real life settings in patients with CTCL. [Срок оценки: The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)]
Вторичные конечные точки (5)
- To identify real life patients' baseline clinical characteristics (e.g. CTCL subtype, cutaneous, lymphatic and blood involvement (TNMB), staging). [Срок оценки: The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)]
- Evaluate the effectiveness of each different systemic treatment trough evaluation of best ORR attained at any time (ORRb). [Срок оценки: The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)]
- Overall Survival of enrolled patients. [Срок оценки: The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)]
- Evaluate the safety of each different systemic treatments. [Срок оценки: The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)]
- Impact of new drugs (brentuximab vedotin and mogamulizumab). [Срок оценки: The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)]
Критерии участия
Критерии включения
- Confirmed diagnosis of CTCL according to the EORTC 2017 update criteria1.
- Age ≥18 years.
- Have received first dose of a systemic therapy, lasted at least 3 months, between 1 January 2016 and 31 December 2023.
- Availability of complete medical records in order to provide protocol required variables
- Signed written informed consent.
Критерии исключения
- Patients not meeting the above-mentioned inclusion criteria.
- Refuse to sign a written informed consent.
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 · 18 центров
- AOU Ospedali Riuniti delle Marche - Clinica di Ematologia — Ancona
- IRCCS Istituto Tumori Giovanni Paolo II - U.O.C. Ematologia — Bari
- U.O.C. Dermatologia e Venereologia Universitaria - A.O.U. Policlinico Consorziale — Bari
- Policlinico S.Orsola-Malpighi - Istituto di Ematologia — Bologna
- ASST Spedali Civili di Brescia - S.C. Ematologia — Brescia
- A.O. Brotzu Ospedale Businco - S.C. Ematologia e CTMO — Cagliari
- A.O.U. Policlinico S. Marco - U.O.C. di Ematologia — Catania
- Unità funzionale di Ematologia - Azienda Ospedaliera Universitaria Careggi — Florence
- … и ещё 10 центров
Идентификаторы
NCT: NCT06588868 · FIL_CTCL