Characteristics, Treatment and Outcomes of HIV-infected Patients With Malignant Lymphoma: A Registry Study of the European Hematology Association (EHA) Lymphoma Group
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 6
- 主要终点
- 2-year overall survival (OS)
研究概览
简要总结
Retrospective und prospective registry on HIV-associated lymphoma. Data on characteristics, type and toxicity of treatment and outcome of patients with HIV-lymphoma will be collected.
详细描述
To study characteristics, treatment approaches and outcome of HIV-infected patients with malignant lymphoma in the combination antiretroviral therapy (cART) era. HIV-infected persons diagnosed with non-Hodgkin lymphoma or Hodgkin lymphoma will be included. The choice of treatment is not specified by the registry study. However, the type of antineoplastic treatment should follow national or international recommendations and guidelines. Data will be pseudonymized by the data manager of the treating institution. Central data management is located at Red Cross Hospital Munich, Germany.
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
- •Histology or cytology proven non-Hodgkin lymphoma or Hodgkin lymphoma
- •HIV-infection at time of lymphoma diagnosis
- •Lymphoma diagnosis since 01.01.2010
- •Adult patients ≥ 18 years
- •Written informed consent
排除标准
- •HIV-diagnosis > 3 months after the diagnosis of malignant lymphoma
- •Non-Compliance or lack of opportunity for follow-up (for the prospective part of the study)
结局指标
主要结局
2-year overall survival (OS)
时间窗: 2 years
OS measured from the date of diagnosis to last follow-up or to death from any cause.
2-year progression-free survival (PFS)
时间窗: 2 years
PFS calculated from the date of diagnosis to the time of progression, relapse, or death.
次要结局
- Incidence of relapse (IR)(5 years)
- Non-relapse mortality (NRM)(5 years)
- 5-year overall survival (OS)(5 years)
- 5-year progression-free survival (PFS)(5 years)
研究者
Prof. Marcus Hentrich
Head of the Department of Hematology and Oncology
Rotkreuzklinikum München gGmbH