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.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Primary Mediastinal Large B-cell Lymphoma (PMBCL)
- Sponsor
- IRCCS San Raffaele
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- TREATMENT STRATEGY
- Status
- Active, not recruiting
- Last Updated
- 12 months ago
Overview
Brief Summary
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.
Investigators
Andrés José Maria Ferreri
Oncologist
IRCCS San Raffaele
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •Patients with CNS lymphoma other than PMLBCL subtype
Outcomes
Primary Outcomes
TREATMENT STRATEGY
Time Frame: 2003-2020
to correlate treatment strategy with survival end-points
OS
Time Frame: 2003-2020
to evaluate Overall Survival ( OS) after CNS relapse
MOLECULAR DIAGNOSTIC
Time Frame: 2003-2020
to central pathological reviewed the initial diagnosis and the relapse and to correlate biological and molecular factors with CNS recurrence
CNS RELAPSE
Time Frame: 2003-2020
to describe the median time to CNS relapse
PT CHARACTERISTICS
Time Frame: 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
Time Frame: 2003-2020
to define prognostic factors of outcome of CNS relapse in PMLBCL patients
PFS
Time Frame: 2003-2020
to evaluate the Progression Free Survical ( PFS) after CNS events