Primary Mediastinal Large B-cell Lymphoma With CNS Involvement
- Conditions
- Primary Mediastinal Large B-cell Lymphoma (PMBCL)
- Registration Number
- NCT06024694
- Lead Sponsor
- IRCCS San Raffaele
- Brief Summary
retrospective 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 45
- 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
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical characteristics 2 2 YEARS to correlate treatment strategy with survival end-points
Clinical characteristics 3 2 YEARS to evaluate the Progression Free Survical ( PFS) after CNS events
Clinical characteristics 1 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 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Ospedale San Raffaele
🇮🇹Milan, Italy