Observational, Post-authorization, Cross-sectional Study to Evaluate the Prognostic Value of Clinical and Biological Factors in Patients With Refractory/Relapsed Diffuse Large B-cell Lymphoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 158
- 试验地点
- 56
- 主要终点
- R-IPI Index (Revised International Prognostic Index)
研究概览
简要总结
The purpose of this study is to evaluate the prognostic value of clinical and biological factors in patients with refractory/relapsed Diffuse Large B-Cell Lymphoma.
详细描述
The main aim of this study is to compare the prognostic value of R-IPI at diagnosis and relapse, relating it with the obtained response after second line
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
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
R-IPI Index (Revised International Prognostic Index)
时间窗: At the beginning of the 2nd line of treatment, an average of 2 years
The IPI is based on the evaluation of 5 clinical factors: age \> 60 years Ann Arbor stage III or IV disease \> 1 extra nodal site European Cooperative Oncology Group performance status (ECOG PS) _ 2, increased serum LDH (lactate dehydrogenase) levels Revised IPI (R-IPI) evaluates the same parameters, but groups them differently to form 3 prognostic groups of patients with significantly different progression-free survival and overall survival outcomes.
Predictive Value of R-IPI at Diagnosis
时间窗: At diagnosis
次要结局
- p-53 Expression(At diagnosis)
- p53 Expression(At the beginning of the 2nd line of treatment)
- Multiple Myeloma Oncogene 1 (MUM-1) Expression(At diagnosis)
- Bcl-2 Expression(At the beginning of the 2nd line of treatment)
- Bcl-6 Expression(At the beginning of the second line of treatment)
- MUM-1 Expression(At the beginning of the 2nd line of treatment)
- Ann Arbor Staging(At the beginning of the 2nd line of treatment)
- Response to First Line of Treatment(After first line treatment)
- Response to Second Line of Treatment(After second line of treatment)
- Relationship Between Global Response Rate to 2nd (Second) Line of Treatment and Bcl-2 Expression at Diagnosis(At diagnosis)
- Relationship Between Global Response Rate to 2nd Line of Treatment and Bcl-6 Expression at Diagnosis(At diagnosis)
- Relationship Between Global Response Rate to 2nd Line of Treatment and Multiple Myeloma Oncogene 1 (MUM1) Expression at Diagnosis(At diagnosis)
- Eastern Cooperative Oncology Group Performance Status (ECOG) Performance Status(At the beginning of the 2nd line of treatment)
- Relationship Between Global Response Rate to 2nd Line of Treatment and p53 Expression at Diagnosis(At diagnosis)