Indolent Non Follicular Lymphomas Prognostic Project - Prospective Collection of Data of Possible Prognostic Relevance in Patients With Indolent Non-follicular B-CELL Lymphomas
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 370
- 试验地点
- 46
- 主要终点
- Progression-free survival for the treated cohort
研究概览
简要总结
Prospective collection of data of possible prognostic relevance in patients with indolent non - follicular B-CELL Lymphomas.
详细描述
The present study is designed as a prospective collection of information potentially useful to predict the prognosis of newly diagnosed patients with non-follicular low grade B-cell lymphoma.
The study is aimed to verify whether a prognostic collection of data would allow the development of a more accurate prognostic assessment for non-follicular low grade B-cell lymphomas.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically confirmed diagnosis of non-follicular low grade B-cell lymphoma
- •Splenic MZL (bone marrow histology and/or spleen tissue)
- •Extranodal MZL of MALT (tissue biopsy)
- •Nodal MZL (lymph node biopsy)
- •Lymphocytic lymphoma (lymph node biopsy)
- •Lymphoplasmacytic lymphoma (bone marrow histology or lymph node biopsy)
- •CD5-negative low grade B-cell lymphoma (bone marrow histology)
- •Age over 18
- •Written informed consent
排除标准
- 未提供
结局指标
主要结局
Progression-free survival for the treated cohort
时间窗: September 2024 (13 years)
Progression free survival (PFS) will be measured from the date of randomization to the date of documented first occurrence of disease progression or relapse or to the date of death from any cause. Patients who are lost to follow up will be censored at their last assessment date.
次要结局
- Progression-free survival for the untreated cohort(September 2024 (13 years))
- Overall survival(September 2024 (13 years))
- Event-free survival(September 2024 (13 years))
- Time dependent analysis for patients in Watch & Wait policy.(September 2024 (13 years))
- Remission rate with initial therapy(September 2017 (Six years))
- Epidemiology(September 2016 (Five years))
- Remission rates with second and subsequent lines of therapy(September 2024 (13 years))