Prevention of Graft Rejection in Hematopoietic Stem Cell Transplant (HSCT) Recipients
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: Emapalumab 3 mg/kg, Emapalumab 10 mg/kg.
- Кому может быть актуально
- Состояния в реестре: Hematopoietic Stem Cell Transplantation, Graft Failure. Базовые параметры: Без ограничений · 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 →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Официальное название
Emapalumab for the Prevention of Graft Rejection in Hematopoietic Stem Cell Transplant (HSCT) Recipients
Обзор
The investigators hypothesize that graft rejection after hematopoietic stem cell transplant (HSCT) is primarily driven by interferon gamma, and prophylactic interferon gamma inhibition in high-risk patients will prevent graft rejection. Additionally, knowledge of emapalumab PK/PD and in vitro mechanistic effects of emapalumab in this novel setting will guide optimization of dosing regimens and treatment approaches in future studies.
Подробное описание
Graft rejection is a devastating and understudied complication of hematopoietic stem cell transplant (HSCT) due to the lack of available interventions outside of re-transplantation. Re-transplantation is challenging and is associated with increased morbidity and mortality.
The purpose of this study is to learn more about emapalumab and its ability to prevent graft rejection in hematopoietic stem cell transplant (HSCT) recipients. Specifically, the study doctors would like to learn more about the efficacy and treatment of emapalumab as a prophylactic intervention for graft rejection.
Вмешательства
- Препарат Emapalumab 3 mg/kg
Subjects will be randomized to either receive a 3mg/kg or 10mg/kg intravenous dose of emapalumab once and may receive up to two additional doses if clinical concern for impending graft rejection develops. - Препарат Emapalumab 10 mg/kg
Subjects will be randomized to either receive a 3mg/kg or 10mg/kg intravenous dose of emapalumab once and may receive up to two additional doses if clinical concern for impending graft rejection develops.
Первичные конечные точки
- Preliminary efficacy of Emapalumab [Срок оценки: 100 days]
Вторичные конечные точки (12)
- Maximum plasma concentration (Cmax) of emapalumab after 10 mg/kg prophylactic dosing [Срок оценки: Until day 42 or time of rescue dose, whichever is sooner]
- Maximum plasma concentration of emapalumab after 3 mg/kg prophylactic dosing [Срок оценки: Until day 42 or time of rescue dose, whichever is sooner]
- Maximum plasma concentration of emapalumab after rescue dosing [Срок оценки: Until day 42 or 1 week after rescue dose, whichever is later]
- Number of patients in 10 mg/kg prophylactic dosing arm who maintain CXCL9 levels below the upper limit of normal for the test (</= 647 pg/mL). [Срок оценки: Until day 42 or 1 week after rescue dose, whichever is later]
- Number of patients in 3 mg/kg prophylactic dosing arm who maintain CXCL9 levels below the upper limit of normal for the test (</= 647 pg/mL). [Срок оценки: Until day 42 or 1 week after rescue dose, whichever is later]
- Number of patients in 10 mg/kg prophylactic dosing arm who maintain CXCL9 levels below 2.6x the upper limit of normal for the test. [Срок оценки: Until day 42 or 1 week after rescue dose, whichever is later]
- Number of patients in 3 mg/kg prophylactic dosing arm who maintain CXCL9 levels below 2.6x the upper limit of normal for the test. [Срок оценки: Until day 42 or 1 week after rescue dose, whichever is later]
- Emapalumab half-life after 10 mg/kg prophylactic dosing [Срок оценки: Until day 42 or time of rescue dose, whichever is sooner]
- Emapalumab half-life after 3 mg/kg prophylactic dosing [Срок оценки: Until day 42 or time of rescue dose, whichever is sooner]
- Emapalumab half-life after 10mg/kg rescue dosing [Срок оценки: Until day 42 or time of rescue dose, whichever is sooner]
- Overall survival [Срок оценки: 100 days after HSCT.]
- Number of patients who develop infections [Срок оценки: 100 days after HSCT.]
Критерии участия
Критерии включения
- All patients undergoing allogeneic HSCT at our institution will be evaluated for graft rejection risk factors. Patients deemed high risk for graft rejection will have 2 or more of the following: mismatched or haploidentical donor, ex vivo t-cell depleted graft, prior history of graft rejection.
Критерии исключения
- Known hypersensitivity to any constituent of the study medication.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Четверное слепое
- Основная цель
- Лечение
Центры проведения
США · 1 центр
- Cincinnati Children's Hospital Medical Center — Cincinnati
Идентификаторы
NCT: NCT07244419 · 2024-0167