Набор скоро начнётся NCT07713511

INfections in Patients Treated With CAR-T

— Наблюдательное Relapsed Multiple Myeloma Refractory Multiple Myeloma B-Cell Non-Hodgkin Lymphoma Bloodstream Infections

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: Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально: Состояния в реестре: Relapsed Multiple Myeloma, Refractory Multiple Myeloma, B-Cell Non-Hodgkin Lymphoma, Bloodstream Infections. 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: Италия
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

INfections in Patients Treated With CAR-T: Analysis of Incidence, Risk Factors, and Management Strategies

Обзор

This study includes adults with multiple myeloma or B-cell lymphoma who were/will be treated with CAR-T cell therapy at the IRCCS Azienda Ospedaliero-Universitaria di Bologna. The aim is to better understand infections that may occur during the first year after CAR-T treatment, including how often they happen, their causes, and factors that may increase the risk. The study will use information from patients treated in the past and from newly enrolled patients. For some patients who develop fever after CAR-T therapy, a rapid molecular blood test will be used alongside standard tests to help identify bloodstream infections more quickly and support timely clinical care.

Подробное описание

This is a single-center observational study involving adult patients with relapsed/refractory multiple myeloma or B-cell non-Hodgkin lymphoma who received/will receive CAR-T cell therapy at the IRCCS Azienda Ospedaliero-Universitaria di Bologna. The study aims to evaluate how often infections occur during the first 12 months after CAR-T infusion and to describe their main characteristics and risk factors. Both patients treated since 2019 (retrospective cohort) and newly enrolled patients during the year following study approval (prospective cohort) will be included, with one year of follow-up after infusion.

The study will investigate factors associated with infection risk, the impact of preventive and therapeutic anti-infective strategies, the distinction between infection-related fever and cytokine release syndrome (CRS), post-discharge infections, and immune recovery after CAR-T therapy. In the prospective cohort, patients who develop their first fever episode after CAR-T infusion will also undergo a validated rapid molecular blood test (PilotGene ddPCR Blood System), alongside standard blood cultures, to improve the speed of bloodstream infection diagnosis. The test is already used in clinical practice and will serve as a complementary diagnostic tool without changing standard patient management. Approximately 290 patients are expected to be included, most of whom with lymphoma.

Первичные конечные точки

Cumulative Incidence of Participants With at Least One Infectious Complication After CAR-T Infusion. [Срок оценки: Within 12 months after CAR-T infusion]

Вторичные конечные точки (5)

Adjusted Odds Ratios for Predefined Pre- and Post-Infusion Factors Associated With Infectious Complications. [Срок оценки: Within 12 months after CAR-T infusion]
Classification of the first febrile episode within 30 days after CAR-T infusion. [Срок оценки: Within the first 30 days after CAR-T infusion]
Participants with microbiologically documented infection at the first febrile episode. [Срок оценки: Within the first 30 days after CAR-T infusion.]
Post-Discharge Infectious Complications. [Срок оценки: From hospital discharge up to 12 months after CAR-T infusion.]
Diagnostic Yield of the Pilot Gene ddPCR Blood Test. [Срок оценки: Up to 12 months after enrollment (at the first febrile episode)]

Критерии участия

Критерии включения

Diagnosis of relapsed/refractory multiple myeloma or B-cell non-Hodgkin lymphoma, including diffuse large B-cell lymphoma, not otherwise specified (DLBCL-NOS), high-grade B-cell lymphoma (HGBCL), primary mediastinal B-cell lymphoma (PMBCL), follicular lymphoma (FL) and mantle cell lymphoma (MCL)
Receipt of CAR-T infusion at IRCCS AOUBo
Age ≥18 years at the time of CAR-T infusion
Signed informed consent