Single-center, Retrospective Study Aimed to Perform a Molecular Characterization of Aggressive B-cell Lymphomas (Diffuse Large B-cell Lymphoma, High-grade B-cell Lymphoma With MYC and BCL2 and/or BCL6 Translocations, High-grade B-cell Lymphoma Not Otherwise Specified) and to Observe the Clinical Patients' Outcomes According to the 2017 WHO Classification
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 555
- 试验地点
- 1
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
This is a retrospective analysis of the presence of chromosomal rearrangements involving MYC, BCL2 and BCL6 genes by FISH in a retrospective, single-center series of large B-cell lymphomas, in order to allow a better classifications of these cases according to the current WHO 2017 classification. If this evaluation will be confirmed as a reliable method to reclassify in different groups the evaluated tumors, it can be subsequently routinely apply to indicate the best treatment approaches in this high-risk setting of patients with a significant impact on patients' morbidity and mortality, and also on the health system and related costs.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Overall Survival (OS)
时间窗: From the date of pathologic diagnosis until death from any cause or last follow-up, whichever occurs first, assessed up to 60 months
Overall survival (OS) is time from the date of pathologic diagnosis until death from any cause or last follow-up, whichever occurs first.
次要结局
- Progression-free Survival (PFS)(From the first day of treatment until relapse, progression, death , or last follow-up, whichever occurs first, assessed up to 60 months)
- Overall Response Rate(From the first day of treatment until the date of first documented response assessment, typically within 6 months of treatment initiation)
- Duration of response (DOR; partial response [PR] + complete remission [CR])(From the date of first documented response (CR or PR) until disease progression, relapse, death from any cause, or last follow-up, whichever occurs first, assessed up to 60 months)
- Relapse rates(From the date of first documented response (CR or PR) until disease relapse or last follow-up, whichever occurs first, assessed up to 60 months)
- Relapse Pattern(From the date of first documented response (CR or PR) until disease relapse or last follow-up, whichever occurs first, assessed up to 60 months)
- Incidence of chromosomal rearrangements involving MYC gene and BCL2 gene (so called "double hit lymphoma", representing 60% of HGBL) and/or BCL6 (also called "triple hit lymphoma", representing 20% of HG in Large B-cell Lymphomas.(At the time of pathologic diagnosis (baseline))
研究者
Andrés José Maria Ferreri
MD & Prof.
IRCCS San Raffaele