Идёт набор NCT06785818

Long-term Follow up Local Registry Study of Kymriah in South Korea

— Наблюдательное B-Cell Acute Lymphoblastic Leukemia, Diffuse Large B-Cell 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: Tisagenlecleucel.
Кому может быть актуально: Состояния в реестре: B-Cell Acute Lymphoblastic Leukemia, Diffuse Large B-Cell Lymphoma, Follicular Lymphoma. Базовые параметры: 0 лет — 100 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: South Korea
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

A Registry to Assess Long-Term Safety of Patients With B-Lymphocyte Malignancies Treated With Tisagenlecleucel in South Korea

Обзор

This study is multicenter, primary data collection, non-interventional registry study to assess long-term safety, secondary malignancy risk, and effectiveness of tisagenlecleucel in patients with B-cell malignancies in a routine clinical practice setting in Korea.

Подробное описание

This study will inform on long-term real-world safety and effectiveness of tisagenlecleucel. The primary objective is to evaluate the long-term safety and the risk of secondary malignancies in patients with B lymphocyte malignancies treated with tisagenlecleucel in a real-world setting. The main secondary objective is to evaluate the longterm effectiveness of tisagenlecleucel.

All participants enrolled in this study will be followed up for 15 years from the time of Kymriah® infusion.

Вмешательства

Другое Tisagenlecleucel
This is an observational study. There is no treatment allocation. The decision to initiate tisagenlecleucel will be based solely on clinical judgement.

Первичные конечные точки

The type and frequency of AEs, ADRs, SAEs, SADRs, UAEs, UADRs, USAEs, USADRs, AESI [Срок оценки: Up to 15 years post-infusion]
Identify participants for chimeric antigen receptor (CAR) transgene detection and/or CAR surface expression (if applicable). [Срок оценки: Up to 15 years post-infusion]
Identify presence of replication competent lentivirus (RCL) in blood or tissues [Срок оценки: Up to 15 years post-infusion]

Вторичные конечные точки (12)

B-Cell Acute Lymphoblastic Leukemia - Overall response rate (ORR) [Срок оценки: Up to 15 years post-infusion]
B-Cell Acute Lymphoblastic Leukemia - Duration of response (DOR) [Срок оценки: Up to 15 years post-infusion]
B-Cell Acute Lymphoblastic Leukemia - Relapse-free survival (RFS) [Срок оценки: Up to 15 years post-infusion]
B-Cell Acute Lymphoblastic Leukemia - Event-free survival (EFS) [Срок оценки: Up to 15 years post-infusion]
B-Cell Acute Lymphoblastic Leukemia - Proportion of patients with minimal residual disease (MRD) negative status in bone marrow who achieve a best overall response (BOR) of CR or CRi [Срок оценки: Up to 15 years post-infusion]
Diffuse Large B-Cell Lymphoma - Overall response rate (ORR) [Срок оценки: Up to 15 years post-infusion]
Diffuse Large B-Cell Lymphoma - DOR [Срок оценки: Up to 15 years post-infusion]
Diffuse Large B-Cell Lymphoma - RFS [Срок оценки: Up to 15 years post-infusion]
Diffuse Large B-Cell Lymphoma - Progression-free survival (PFS) [Срок оценки: Up to 15 years post-infusion]
Diffuse Large B-Cell Lymphoma - Overall survival (OS) [Срок оценки: Up to 15 years post-infusion]
Follicular Lymphoma - ORR [Срок оценки: Up to 15 years post-infusion]
Follicular Lymphoma -Complete response rate (CRR) [Срок оценки: Up to 15 years post-infusion]

Критерии участия

Критерии включения

Patients who receive tisagenlecleucel infusion in the commercial setting, treated under a managed access program or other pathway, e.g., when product was manufactured for the commercial setting but turned out to be out of specification (OOS).
Consented to data collection.