Italian Observational Study of Patients With Acute Myeloid Leukemia Treated With Small Molecule Inhibiting B-cell Lymphoma 2 (BCL-2)
试验速览
- 阶段
- 不适用
- 入组人数
- 70
- 试验地点
- 20
- 主要终点
- Incidence of Adverse Events of grade 3 and 4 (NCTCAE version 5.0)
研究概览
简要总结
This is a multi-center retrospective observational study. Every patient with Acute Myeloid Leukemia (AML) treated with anti-B-cell lymphoma 2 (BCL2) treatment outside clinical trial from 1st January 2015 up to 01 April 2019 may be included in this study. No additional drug/procedures/patient visits in comparison with the usual clinical practice are planned for the study. The decision to treat patient with ant-BCL2 inhibitors is made by the physician based on his clinical judgment, independently from the decision to include the patient in this study.
详细描述
In phase 1-2 studies, anti BCL-2 treatment has shown evidence of anti-leukemic activity as single agent and in combination and proved to be particularly effective in providing a deep response, with an acceptable safety profile. Since 2015 anti-BCL2 treatment has been available in other indications and in off-label use in Italy.
In this non-interventional retrospective study, toxicity, effectiveness and costs assessment data will be collected from patients with AML, to improve the knowledge about anti-BCL2 treatment in clinical practice. Collecting and analyzing data from a large unbiased patient-set receiving anti-BCL2, would enlarge our knowledge on therapies inhibiting BCL2.
This is a multi-center retrospective observational study. Every patient with AML treated with anti-BCL2 treatment outside clinical trial from 1st January 2015 up to 01 April 2019 may be included in this study. No additional drug/procedures/patient visits in comparison with the usual clinical practice are planned for the study. The decision to treat patient with ant-BCL2 inhibitors is made by the physician based on his clinical judgment, independently from the decision to include the patient in this study. As this study is intended to be purely observational (not interventional), the patient's medical records will be the source of all data to be recorded. No additional procedures/patient visits should be planned in the study with respect to clinical practice.
Clinical data (treatment, survival, adverse events) will be collected for patients enrolled.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Patient with AML according to World Health Organization (WHO) 2016 classification
- •Patient who have received any anti-BCL-2 treatment as single agent or in combination with other drugs from 1 Jan 2015 to 1 Apr 2019 outside clinical trials
排除标准
- •Patient who have received any anti-BCL-2 treatment within a clinical trials
结局指标
主要结局
Incidence of Adverse Events of grade 3 and 4 (NCTCAE version 5.0)
时间窗: up to 18 months
To evaluate the toxicity profile of the therapy with anti-BCL-2 in patients with AML.
次要结局
- Minimal Residual Disease(18 months)
- Complete Remission(18 months)
- Collection of number of clinical visits per patient(18 months)
- Incidence of successful bridge to allogeneic transplant(18 months)
- Collection of number of accesses in Emergency Care Units per patient(18 months)
- Overall Survival(18 months)
- Disease Free Survival (DFS)(18 months)
- Complete Remission with incomplete hematologic recovery(18 months)
- Collection of number of hospitalizations(18 months)
- Collection of days of hospitalizations(18 months)
- Collection of number of accesses Day Hospital per patient(18 months)