Retrospective Multicenter International Study on Prognostic Factors, Management And Outcome Of Primary Mediastinal Large B-Cell Lymphoma (PMLBCL) Patients With Central Nervous System (CNS) Involvement
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Clinical characteristics 2
研究概览
简要总结
This is a retrospective, multicenter study focused on patients with a known diagnosis of PMLBCL which experienced a CNS relapse during the course of their disease to obtain information about the clinical characteristics, the management at diagnosis and at each relapses , and the outcome of these cases. The aim of the study is to put together the large International series on CNS+ PMLBCL data, coming from 6 different countries , on clinical factors, anti-lymphoma therapy administered alone or concomitant with CNS prophylaxis , the information about the site of re biopsy when available , the dose intensity of lymphoma therapy received at relapse and the outcome of patients.
Both patients treated in routine practice or within clinical trials will be considered. Moreover to better characterized the pathological features of this rare entity a central pathological review of the initial diagnosis and when available of for histological confirmed relapse will be considered.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
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
- •Histologically confirmed diagnosis of Primary Mediastinal Large B Cell Lymphoma (PMLBCL) according WHO Classification
- •Had a recurrence/progression with Central Nervous System (CNS) involvement
- •Availability of details on clinical presentation, treatment details and outcome
- •Availability of details on pathological data for central review
- •Age ≥18 years
- •Exclusion Criteria
- •Patients with CNS lymphoma other than PMLBCL subtype
排除标准
- 未提供
结局指标
主要结局
Clinical characteristics 2
时间窗: 2 YEARS
to correlate treatment strategy with survival end-points
Clinical characteristics 3
时间窗: 2 YEARS
to evaluate the Progression Free Survical ( PFS) after CNS events
Clinical characteristics 1
时间窗: 2 YEARS
to describe the PMLBCL characteristics at diagnosis and at CNS relapse ( first relapse or second and subsequent recurrences) and the treatment received to describe the median time to CNS relapse to define prognostic factors of outcome of CNS relapse in PMLBCL patients
Clinical characteristics 4
时间窗: 2 YEARS
to evaluate Overall Survival ( OS) after CNS relapse to centra! pathological reviewed the initial diagnosis and the relapse and to correlate biological and molecular factors with CNS recurrence
次要结局
未报告次要终点
研究者
Andrés José Maria Ferreri
Lymphoma Unit Director
IRCCS San Raffaele
