Outcomes After Chimeric Antigen Receptor Therapy and Radiation Therapy for Hematologic Malignancies
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: Data Capture, Electronic Medical Record.
- Кому может быть актуально
- Состояния в реестре: Hematopoietic and Lymphoid Cell Neoplasm. 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
- 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
Outcomes After Chimeric Antigen Receptor Therapy (CAR-T) and Radiation Therapy (RT) for Hematologic Malignancies
Обзор
This study collects information on outcomes after chimeric antigen receptor therapy and radiation therapy for hematologic malignancies. Collecting information from patients before, during, and after receiving chimeric antigen receptor therapy or radiation therapy may help doctors to optimize patient selection, dose, timing, and sequencing of these treatments.
Подробное описание
PRIMARY OBJECTIVE:
I. Record clinical outcomes of patients with hematologic malignancies receiving standard-of-care chimeric antigen receptor therapy (CAR-T) nd/or standard-of- care bispecific therapy, and radiation therapy (RT).
SECONDARY OBJECTIVES:
I. To record patient-specific factors and treatment-related factors in patients with hematologic malignancies receiving standard-of-care CAR-T, and/or standard-of-care bispecific therapy, and RT to ultimately improve patient selection and overall treatment strategy to optimize clinical outcomes. II. To record and explore the relationship between radiation dose, target, technique, and timing with respect to CAR-T, and/or standard-of-care bispecific therapy and clinical outcomes in patients with hematologic malignancies treated with standard-of-care CAR-T, and/ or standard-of-care bispecific therapy, and RT.
III. To record and study the relationship between patient-specific factors and treatment-related factors and treatment toxicity in patients with hematologic malignancies undergoing standard-of-care CAR-T, and/or standard-of-care bispecific therapy, and RT.
OUTLINE:
Patients medical records are reviewed for details about CAR-T and RT treatment and acute and late toxicities, disease outcomes such as any events related to local or distant disease progression, survival, and cause of death if available. Patients' imaging scan data is collected at baseline, within 2 months of the first treatment of RT or CAR-T, and at 3, 6, 12 months, and then annually for 5 years after RT completion.
Вмешательства
- Другое Data Capture
Treatment related data is collected - Другое Electronic Medical Record
Medical records are reviewed
Первичные конечные точки
- Clinical outcomes of patients with hematologic malignancies receiving standard-of-care chimeric antigen receptor therapy (CAR-T) and radiation therapy (RT) [Срок оценки: Up to 5 years]
Вторичные конечные точки (3)
- Patient-specific factors and treatment-related factors [Срок оценки: Up to 5 years]
- Relationship between radiation dose, target, technique, and timing with respect to CAR-T and clinical outcomes [Срок оценки: Up to 5 years]
- Relationship between patient-specific factors and treatment-related factors and treatment toxicity [Срок оценки: Up to 5 years]
Критерии участия
Критерии включения
- Age 18 years or older
- Treatment with or intention to treat with radiation therapy, standard-of-care CAR-T cell therapy and/or standard-of-care bispecific therapy, within a 90 day window for a hematologic malignancy
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 · 1 центр
- M D Anderson Cancer Center — Houston
Идентификаторы
NCT: NCT04888338 · 2020-1150 · NCI-2021-00910 · 2020-1150