Multicenter Retrospective Observational Study of Relapsed Diffuse Large B-Cell Lymphoma Presenting as Indolent Lymphoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
Most relapses of diffuse large B-cell lymphoma (DLBCL) occur as high-grade lymphoma within the first two years after diagnosis. Relapses as indolent lymphoma are rare events, and the true incidence of this phenomenon is unknown, since literature data are scarce/ and usually restricted to case reports. Analogously, reported treatment strategies are rather heterogeneous, since no standard of care is established and advanced age together with previous anthracycline exposure may narrow the therapeutic choice.
The goal of this observational study is to assess epidemiological, clinical characteristics and survival of diffuse large b-cell lymphoma (DLBCL) relapsing as indolent lymphoma.
More precisely, the study aims at identifying diagnostic and imaging features associated with relapse as indolent lymphoma and at evaluating disease response to selected therapies.
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
- •Age 18 years or older at the time of diagnosis.
- •Previous diagnosis of diffuse large B-cell lymphoma with/without a discordant component of indolent B-cell lymphoma, or previous diagnosis of diffuse large B-cell lymphoma transformed from indolent B-cell lymphoma.
- •First-line treatment for diffuse large B-cell lymphoma.
- •Histologically documented relapse of indolent B-cell lymphoma, diagnosed between 2010 and
- •Availability of the histological report of the relapse.
- •Availability of clinical and laboratory data related to both the initial diagnosis and relapse.
- •Availability of follow-up data.
- •Consent to participate in the study and signing of the specific informed consent form (for living and/or contactable patients).
排除标准
- 未提供
结局指标
主要结局
Overall Survival (OS)
时间窗: Up to 2 years
OS is calculated from the date of initiation of treatment for indolent lymphoma relapse to death from any cause or the last follow-up for censored cases.
次要结局
- Progression-Free Survival (PFS)(Up to 2 years)
- Response Rate(Up to 2 years)
- Adverse Events(Up to 2 years)
- Type of Therapy(Up to 2 years)
- Cause of Death(Up to 2 years)