INfections in Patients Treated With CAR-T: Analysis of Incidence, Risk Factors, and Management Strategies
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 290
- 试验地点
- 1
- 主要终点
- Cumulative Incidence of Participants With at Least One Infectious Complication After CAR-T Infusion.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
结局指标
主要结局
Cumulative Incidence of Participants With at Least One Infectious Complication After CAR-T Infusion.
时间窗: Within 12 months after CAR-T infusion
Percentage of participants experiencing at least one infectious complication of any type within 12 months after CAR-T infusion.
次要结局
- Adjusted Odds Ratios for Predefined Pre- and Post-Infusion Factors Associated With Infectious Complications.(Within 12 months after CAR-T infusion)
- Classification of the first febrile episode within 30 days after CAR-T infusion.(Within the first 30 days after CAR-T infusion)
- Participants with microbiologically documented infection at the first febrile episode.(Within the first 30 days after CAR-T infusion.)
- Post-Discharge Infectious Complications.(From hospital discharge up to 12 months after CAR-T infusion.)
- Diagnostic Yield of the Pilot Gene ddPCR Blood Test.(Up to 12 months after enrollment (at the first febrile episode))