Идёт набор NCT05541341

Effectiveness and Safety of Tisagenlecleucel Therapy in Brazilian Patients With B-lymphocyte Malignancies

— Наблюдательное Diffuse Large B-cell Lymphoma Acute Lymphoblastic Leukemia 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: Diffuse Large B-cell Lymphoma, Acute Lymphoblastic Leukemia, 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: Бразилия
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

Effectiveness and Safety of Tisagenlecleucel Therapy in Brazilian Patients With B-lymphocyte Malignancies: a 15-year Prospective Registry Study on Three Cohorts.

Обзор

This will be a multicenter, national, non-interventional, prospective cohort study

Подробное описание

Eligible participants will be pediatric (\<18 years) and adult patients (aged 18 years or older) with B-cell malignancies who have received tisagenlecleucel through the commercial setting or out-of-specification (OOS) use in Brazil. We will collect data prospectively and complement missing information with retrospective data collection, when necessary. It is anticipated that approximately 200 patients will be enrolled in the cohort over 5 years divided among the study indications.

Since this is a non-interventional study, no administration of study drug or application of questionnaires will be mandated by this protocol. The study will consist of a "Pre-infusion" and a "Post infusion follow-up period" for up to 15 years post tisagenlecleucel infusion. All patients will be followed until death or last scheduled visit, whichever comes first.

For the study, "pre-infusion" and "follow-up post infusion" phases are defined as:

* "Pre-infusion" will consist of the patient's information from the time of diagnosis untiljust prior to infusion with tisagenlecleucel. * "Follow-up Post infusion" information will comprise any information from the infusionof tisagenlecleucel onwards.

Вмешательства

Другое tisagenlecleucel
Prospective observational study. There is no treatment allocation. Patients prescribed with tisagenlecleucel in the commercial setting or out-of-specification (OOS) are eligible to enroll into this study

Первичные конечные точки

Overall response rate (ORR) [Срок оценки: Up to 15 years]
MRD negative overall response rate [Срок оценки: Up to 15 years]
Duration of overall response (DOR) [Срок оценки: Up to 15 years]
Relapse-free survival (RFS) [Срок оценки: Up to 15 years]
Event-free survival (EFS) for ALL patients [Срок оценки: Up to 15 years]
Progression free survival (PFS) for DLBCL patients [Срок оценки: Up to 15 years]
Overall survival (OS) [Срок оценки: Up to 15 years]
Number of ALL patients with hematologic recovery [Срок оценки: Up to 15 years]

Вторичные конечные точки (4)

The type and frequency of SAEs and AE of special interest [Срок оценки: Up to 15 years]
Incidence and severity of CRS and ICANS among HTLV 1 and 2 positive versus HTLV 1 and 2 negative patients [Срок оценки: Up to 15 years]
Pregnancy rates [Срок оценки: Up to 15 years]
Number of patients with confirmed secondary malignancies diagnosis [Срок оценки: Up to 15 years]

Критерии участия

Критерии включения

Patients eligible for inclusion in this study must meet the following criteria:

Patients who receive tisagenlecleucel infusion in the commercial setting or out-of-specification (OOS) use, AND
Signed informed consent must be obtained prior to participation in study, AND

For ALL participants:

Patients of any gender aged 0-17 years (named as pediatric) with relapsed/ refractory B-cell ALL diagnosis that received tisagenlecleucel infusion, OR
Patients of any gender, aged 18-25 years (named as adults) - with relapsed/ refractory B-cell ALL diagnosis that received tisagenlecleucel infusion, OR

For DBLCL and FL participants:

Patients of any gender aged 18 years or older, who have been diagnosed with relapsed/ refractory Diffuse Large B-cell Lymphoma and received tisagenlecleucel infusion.