Prospective Collection of Biological Data of Prognostic Relevance in Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 495
- 试验地点
- 1
- 主要终点
- Prospective validation of the prognostic potential of a score system based on the presence/absence of three risk factors (VH mutational status, Zap-70 and CD38 expression) on Progression Free Survival (PFS ).
研究概览
简要总结
The purpose of the present study is to develop a biological prognostic index in patients with Binet stage A Chronic Lymphocytic Leukemia (CLL) who do not necessitate therapy according to NCI guidelines and to prospectively validate the proposed score system based on the absence/presence of 1, 2 or 3 unfavorable prognostic markers such as cluster of differentiation 38 (CD38) expression, Zap-70 expression and immunoglobulin heavy chain variable region (IgVH) configuration.
详细描述
Clinical data including information on disease localization and laboratory parameters will be collected at study entry, during follow up and at disease progression (or after 36 months after registration) Biological markers will be evaluated at centralized laboratory, at study entry and at time of disease progression (or after 24 months of follow-up for non progressed patients) Using the scoring system, patients can be separated into 3 risk groups: low-risk (score 0), intermediate-risk (score 1) and high-risk (score 2-3), with significantly different clinical courses.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Established diagnosis of B-CLL by NCI criteria, performed by local haematologist. (Diagnosis will be confirmed by the biological review committee according to flow cytometry analysis (positive clusters of differentiation antigen 5 (CD5), 19 (CD19),23 (CD23)).
- •Age > 18 years and < 70 years.
- •Eastern Cooperative Oncology Group (ECOG)<=
- •Binet stage A.
- •Diagnosis performed within 12 months before inclusion in the study.
- •Patients who do not necessitate therapy by NCI guidelines (watch and wait policy).
- •Shipment of peripheral blood sample to centralized laboratory for biological assessment.
- •Clinical data including baseline information on disease localization and laboratory parameters at staging and assurance of follow up updating for at least 3 years are requested.
- •Written informed consent.
排除标准
- •Patients with CLL whose diagnosis exceed 12 months before registration.
- •Patients with leukemic phase of lymphoproliferative disorders of B origin CD5- and/or CD23- according to flow cytometry analysis.
- •Clinical Binet stage B or C.
- •Patients who necessitate therapy according to NCI guide-lines (no watch and wait policy).
- •Age > 70 years.
- •Without a written informed consent.
结局指标
主要结局
Prospective validation of the prognostic potential of a score system based on the presence/absence of three risk factors (VH mutational status, Zap-70 and CD38 expression) on Progression Free Survival (PFS ).
时间窗: 6 months
次要结局
- Quality of Life(6 months)
- Time to Treatment(6 months)
- Overall Survival(3 years)