跳至主要内容
临床试验/NCT06024694
NCT06024694进行中(未招募)不适用

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

IRCCS San Raffaele1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2022年6月30日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Andrés José Maria Ferreri

Lymphoma Unit Director

IRCCS San Raffaele

研究点 (1)

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