Long-term Follow-up of Patients Treated With Genetically Modified Autologous T Cells
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: AUTO CAR T cell therapy.
- Кому может быть актуально
- Состояния в реестре: Patients Followed for up to 15 Years Following Their First Dose of AUTO CAR T Cell Therapy, Multiple Myeloma, DLBCL, ALL, Adult and Pediatric. Базовые параметры: от 1 год · 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
- США, Великобритания
- 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
Long-term Follow-up of Patients Previously Treated With Autologous T Cells Genetically Modified With Viral Vectors
Обзор
Long-term follow-up of patients exposed to an AUTO CAR T cell therapy for up to 15 years following their first AUTO CAR T cell therapy infusion.
Подробное описание
The purpose of this study is to monitor all patients exposed to an AUTO CAR T cell therapy, for up to 15 years following their first AUTO CAR T cell therapy infusion to assess the risk of delayed treatment-related SAEs, adverse events of special interest (AESIs), monitor for emergence of replication competent retrovirus (RCR) or replication competent lentivirus (RCL), monitor for the emergence of a new malignancy associated with insertional mutagenesis (insertion site analysis), assess CAR transgene persistence and assess long-term efficacy. Monitoring of such long-term effects of AUTO CAR T cell therapy will help to further define the risk-benefit profile of these new CAR T cell therapies.
Вмешательства
- Биопрепарат AUTO CAR T cell therapy
No study drug is administered in this study. Patients previously treated with AUTO CAR T cell therapy will be monitored for safety following the first infusion.
Первичные конечные точки
- Incidence of Serious Adverse Events (SAE), new malignancies & adverse events of special interest (AESI) related to AUTO CAR T cell therapy [Срок оценки: For up to 15 years]
Вторичные конечные точки (7)
- Overall Survival following first AUTO CAR T cell therapy infusion. [Срок оценки: Month 3, Month 6, Month 9, Month 12 during Year 1 following AUTO CAR T cell therapy infusion, then every 6 months up to Year 5, then yearly up to Year 15]
- Duration of supportive care [Срок оценки: Month 3, Month 6, Month 9, Month 12 during Year 1 following AUTO CAR T cell therapy infusion, then every 6 months up to Year 5, then yearly up to Year 15]
- Duration of response [Срок оценки: Month 3, Month 6, Month 9, Month 12 during Year 1 following AUTO CAR T cell therapy infusion, then every 6 months up to Year 5, then yearly up to Year 15]
- Progression-free survival [Срок оценки: Month 3, Month 6, Month 9, Month 12 during Year 1 following AUTO CAR T cell therapy infusion, then every 6 months up to Year 5, then yearly up to Year 15]
- Proportion of patients with detectable replication-competent retrovirus (RCR) or lentivirus (RCL) from first AUTO CAR T cell therapy infusion [Срок оценки: For up to 15 years]
- Proportion of patients with detectable vector copy number (VCN) in peripheral blood [Срок оценки: Month 3, Month 6, Month 9, Month 12 during Year 1 following AUTO CAR T cell therapy infusion, then every 6 months up to Year 5, then yearly up to Year 15]
- Testing for Insertional mutagenesis in case of a new malignancy [Срок оценки: For up to 15 years]
Критерии участия
Критерии включения
- Patients must have received an AUTO CAR T cell therapy on a clinical treatment study.
- Patients must have provided informed consent for long-term follow-up study prior to participation.
- Patients must be able to comply with the study requirements.
Критерии исключения
- There are no specific exclusion criteria for this study.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Другое
Центры проведения
Великобритания · 5 центров
- Queen Elizabeth University Hospital — Glasgow
- University College London Hospitals NHS Foundation Trust — London
- Manchester Royal Infirmary Hospital — Manchester
- Royal Manchester Children's Hospital — Manchester
- Freeman Hospital, The Newcastle upon Tyne Hospitals NHS Foundation Trust — Newcastle upon Tyne
США · 3 центра
- University of Miami — Miami
- Washington University in St. Louis — St Louis
- St David's South Austin Medical Center — Austin
Идентификаторы
NCT: NCT03628612 · AUTO-LT1