Prospective Evaluation Of Delayed Effects Of Pediatric Car T Cell Therapy
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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: B-ALL, Hematologic Malignancy, Solid Tumor. Базовые параметры: до 30 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
- США
- 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
Prospective Evaluation Of Delayed Effects Of Pediatric Car T Cell Therapy (PROSPER)
Обзор
This study is being done to learn more about the short-term and long-term side effects of CAR-T cell therapy. Specifically, researchers want to know how often patients get infections, have delays in recovering blood cell counts and/or have damage to the nervous system.
Подробное описание
Primary Objectives
* Bone Marrow Function: To report on the incidence, timing, severity of, and risk factors for bone marrow dysfunction in participants in remission or without bone marrow involvement of disease at 3- and 6-months following CAR T cell therapy. (B-ALL cohort) * Infection/Immune Reconstitution: To evaluate the incidence, timing, severity of and risk factors for clinically significant infections following CAR T cell therapy at 3- and 6-months following CAR T cell therapy. (B-ALL cohort) * Neurotoxicity: To evaluate the incidence, timing, severity of, and risk factors for persistent ICANS at 3- and 6-months post CAR T cell therapy. (B-ALL cohort)
Secondary Objectives
* To evaluate bone marrow function, infection/immune reconstitution, and neurotoxicity at 12 months and 24 months post CAR T cell therapy in participants with B-ALL. * To characterize bone marrow function, infection/immune reconstitution, and neurotoxicity between 3 and 24 months after CAR T cell therapy in other hematologic malignancies and solid tumor cohorts.
Participants will have an assessment of preexisting morbidity and potential risk factors, collection of specimens for banking, scheduled late effects monitoring, laboratory analysis, and screening studies. Data and biospecimens will be collected at 3 months, 6 months, 1 year and 2 years after CAR T cell infusion.
Первичные конечные точки
- Presence of bone marrow dysfunction (BMD) [Срок оценки: Within 6 months post CAR T-cell therapy]
- Occurrence of clinically significant infections [Срок оценки: Within 6 months post CAR T-cell therapy]
- Presence of persistent ICANS [Срок оценки: Within 6 months post CAR T-cell therapy]
Вторичные конечные точки (7)
- Presence of bone marrow dysfunction (BMD) [Срок оценки: Within 24 months post CAR T-cell therapy]
- Severity of BMD [Срок оценки: Within 24 months post CAR T-cell therapy]
- Occurrence of clinically significant infections [Срок оценки: Within 24 months post CAR T-cell therapy]
- Time to the earliest clinically significant infection [Срок оценки: Within 24 months post CAR T-cell therapy]
- Severity of clinically significant infections [Срок оценки: Within 24 months post CAR T-cell therapy]
- Presence of persistent ICANS [Срок оценки: Within 24 months post CAR T-cell therapy]
- Severity of persistent ICANS [Срок оценки: Within 24 months post CAR T-cell therapy]
Критерии участия
Критерии включения
- Participants must have received an initial systemically-administered CAR T cell infusion within the last 1-3 months (+/- 14 days).
- Initial infusion is defined as the first administration of a CAR T cell product the participant has not previously received OR receipt of a CAR T cell product previously received after an interval allogeneic HSCT.
- Age ≤ 30 years at CAR T cell infusion.
Критерии исключения
- Active malignancy other than the disease under study.
- Planned consolidative HSCT within 3 months post CAR T cell infusion.
- Received or planned additional disease directed therapy post CAR T cell infusion.
- Inability or unwillingness of research participant or legal guardian/representative to give 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
США · 6 центров
- Childrens Hospital of Colorado — Aurora
- Children's Hospital of Philadelphia — Philadelphia
- St. Jude Children's Research Hospital — Memphis
- Primary Children's Hospital — Salt Lake City
- Seattle Childrens Hospital — Seattle
- Children's Hospital of Wisconsin. — Milwaukee
Идентификаторы
NCT: NCT06579469 · PROSPER · NCI-2024-06836