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Trial Title:
CNS Involvement in Primary Mediastinal Large B-Cell Lymphoma (PMLBCL)
NCT ID:
NCT05856708
Condition:
Primary Mediastinal Large B-cell Lymphoma (PMBCL)
Conditions: Official terms:
Lymphoma
Lymphoma, B-Cell
Conditions: Keywords:
PMLBCL
CNS
Study type:
Observational
Overall status:
Active, not recruiting
Study design:
Time perspective:
Retrospective
Intervention:
Intervention type:
Other
Intervention name:
DISEASE
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.
Criteria for eligibility:
Study pop:
Patients whose diagnosis met the histological criteria of PMLBL according WHO
classification with a diagnosis of CNS involvement at relapse/progression. Patients
eligible to the study will be retrospectively identified by the site researches by
interrogating the local site sources. Availability of local pathological report at time
of diagnosis and restaging will be considered for eligibility.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
To be eligible for inclusion each patient must fulfil all of the following criteria:
1. Histologically confirmed diagnosis of Primary Mediastinal Large B Cell Lymphoma
(PMLBCL) according WHO Classification
2. Had a recurrence/progression with Central Nervous System (CNS) involvement
3. Availability of details on clinical presentation, treatment details and outcome
4. Availability of details on pathological data for central review
5. Age ≥18 years
Exclusion Criteria:
- Patients with CNS lymphoma other than PMLBCL subtype
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
January 2003
Completion date:
December 2024
Lead sponsor:
Agency:
IRCCS San Raffaele
Agency class:
Other
Source:
IRCCS San Raffaele
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05856708
