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
- TREATMENT STRATEGY
研究概览
简要总结
This is a retrospective, multicenter study designed to collect data on the diagnostic, therapeutic management and outcome of patients diagnosed with primary mediastinal lymphoma who have progressed or relapsed with central nervous system (CNS) involvement.
Through this study, an international data set from 6 different countries will be collected on clinical factors, anti-lymphoma therapy administered alone or in conjunction with CNS prophylaxis, re-biopsy site information when available, dose intensity of lymphoma therapy received at recurrence, and patient outcome.
In addition, to better characterize the pathologic features of this rare entity, a central pathologic review of the initial diagnosis and, if available, histologic confirmation of recurrence will be performed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •To be eligible for inclusion each patient must fulfil all of the following criteria:
- •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
排除标准
- •Patients with CNS lymphoma other than PMLBCL subtype
结局指标
主要结局
TREATMENT STRATEGY
时间窗: 2003-2020
to correlate treatment strategy with survival end-points
OS
时间窗: 2003-2020
to evaluate Overall Survival ( OS) after CNS relapse
MOLECULAR DIAGNOSTIC
时间窗: 2003-2020
to central pathological reviewed the initial diagnosis and the relapse and to correlate biological and molecular factors with CNS recurrence
CNS RELAPSE
时间窗: 2003-2020
to describe the median time to CNS relapse
PT CHARACTERISTICS
时间窗: 2003-2020
to describe the PMLBCL characteristics at diagnosis and at CNS relapse ( first relapse or second and subsequent recurrences) and the treatment received
PROGNOSTIC FACTORS
时间窗: 2003-2020
to define prognostic factors of outcome of CNS relapse in PMLBCL patients
PFS
时间窗: 2003-2020
to evaluate the Progression Free Survical ( PFS) after CNS events
次要结局
未报告次要终点
研究者
Andrés José Maria Ferreri
Oncologist
IRCCS San Raffaele