Идёт набор NCT06733987

Immunological Senescence Phenotype as a Resistance Profile to Pembrolizumab in Patients With Relapsed/Refractory Hodgkin's Lymphoma

— Наблюдательное Hodgkin 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: Hodgkin 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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Обзор

This is a single-centre, observational, prospective and exploratory study, which involves the use of human tissues from patients affected by Relapsed/Refractory classic Hodgkin Lymphoma treated with pembrolizumab at the Departmental Diagnosis and Therapy program for chronic lymphoproliferative syndromes of the IRCCS AOU of Bologna. Peripheral blood samples will be used for the study and will be taken: * before starting treatment with pembrolizumab. * undergoing therapy with pembrolizumab (cycle 2 (C2), C3, C4, C8, C12).

Подробное описание

This is a single-centre, observational, prospective and exploratory study using human tissues from cHL R/R patients treated with pembrolizumab at the IRCCS AOU of Bologna's Diagnosis and Therapy of Chronic Lymphoproliferative Syndromes Departmental Programme. Peripheral blood samples will be used for the study

* before starting treatment with pembrolizumab. * during pembrolizumab therapy (cycle 2 (C2), C3, C4, C8, C12). Patients who have achieved complete metabolic remission will continue pembrolizumab for two years without any consolidation therapy, while those who have achieved a partial response (after about 14-16 doses) will receive allo-transplantation.

Withdrawals will be performed according to clinical practice in accordance with the doctor's judgement. The diagnostic-therapeutic course of the patients will in no way be influenced by the outcome of the tissue examinations that will be carried out for the purposes of the study.

All patients with cHL R/R who are candidates for treatment with pembrolizumab as part of the normal care pathway at the IRCCS AOU of Bologna's Diagnosis and Treatment of Chronic Lymphoproliferative Syndromes Departmental Programme will be prospectively enrolled.

Первичные конечные точки

correlation between immunological profile of SIP and response to pembrolizumab [Срок оценки: At the end of Cycle 2 (each cycle is 21 days)]

Вторичные конечные точки (2)

The correlation of cfDNA with response to therapy [Срок оценки: during pembrolizumab therapy (cycle 2, 3, 4, 8 and12, each cycle is 21 days), through study completion, an average of 2 year]
The correlation of peculiar mutations with response to therapy [Срок оценки: during pembrolizumab therapy (cycle 2, 3, 4, 8 and12, each cycle is 21 days), through study completion, an average of 2 year]

Критерии участия

Критерии включения

Patients of both sexes aged ≥ 18 years at enrollment
Patients affected by cHL R/R candidate to receive a treatment with Pembrolizumab
Signature of informed consent