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Primary Mediastinal Large B-cell Lymphoma With CNS Involvement

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06024694
Enrollment
45
Registered
2023-09-06
Start date
2022-06-30
Completion date
2027-06-10
Last updated
2025-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Mediastinal Large B-cell Lymphoma (PMBCL)

Keywords

CNS, PMLBCL

Brief summary

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.

Interventions

None listed

Sponsors

IRCCS San Raffaele
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Clinical characteristics 12 YEARSto 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 22 YEARSto correlate treatment strategy with survival end-points
Clinical characteristics 32 YEARSto evaluate the Progression Free Survical ( PFS) after CNS events
Clinical characteristics 42 YEARSto 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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026