Observational Study on the Incidence of Infections in Patients With Relapsed/Refractory FMS-like Tyrosine Kinase 3 Acute Myeloid Leukemia Treated With Gilteritinib
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- absolute infectious risk in patients treated with Gilteritinib, Infection events of grade 3 or more ( CTCAE v.5.0 )
研究概览
简要总结
The study is observational, retrospective-prospective, multicenter "real-life" study involving 26 centers belonging to the SEIFEM group. The goal of this study is to obtain a real-life experience in the management and outcome of infectious issues of patients with relapsed/resistant acute myeloid leukemia who receive Gilteritinib therapy, given that recent approval of this drug.
详细描述
The study is observational, retrospective-prospective, multicenter "real-life" study. Regarding the retrospective part, clinical data will be collected on all patients with acute myeloid leukemia FLT3+ treated with Gilteritinib from when the drug was approved and marketed in Italy (April 2, 2020) until April 30, 2022. Enrollment in the prospective cohort will have an estimated duration of 24 months from the time of study approval. Patients enrolled in the last month will be followed for six months from the date of enrollment to check for the occurrence of any infections. For each case of a patient receiving salvage monotherapy with Gilteritinib, a control patient with relapsed/refractory FLT3+ acute myeloid leukemia on salvage chemotherapy should also be included.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients with FLT3+ relapsed/refractory AML to any line of therapy treated with Gilteritinib
- •Patients ≥18 years of age
- •Signature of appropriate informed consent
- •Exclusion criteria:
- •Patients < 18 years old
排除标准
- 未提供
研究组 & 干预措施
Patients who receive or have received Gilteritinib
the retrospective part, clinical data will be collected on all patients with LMA FLT3+ (ITD or TKD mutation) treated with Gilteritinib from when the drug was approved and marketed in Italy (April 2, 2020) until April 30, 2022. Enrollment in the prospective cohort will have an estimated duration of 24 months from the time of study approval.
干预措施: Gilteritinib (Drug)
Case control
for each case of a patient receiving salvage monotherapy with Gilteritinib, a control patient with R/R AML FLT3+ on salvage chemotherapy should also be included.
干预措施: Gilteritinib (Drug)
结局指标
主要结局
absolute infectious risk in patients treated with Gilteritinib, Infection events of grade 3 or more ( CTCAE v.5.0 )
时间窗: 24 months
To assess "real-life" in patients with relapsed/refractory FLT3+ LMA treated with Gilteritinib the absolute infectious risk and compare it with relapsed/refractory patients receiving chemotherapy. The
次要结局
未报告次要终点
研究者
Maria Ilaria Del Principe
Associate Professor
University of Rome Tor Vergata