Primary Mediastinal Large B-cell Lymphoma With CNS Involvement

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.

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Key information

Conditions

Primary Mediastinal Large B-cell Lymphoma (PMBCL)

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ospedale San Raffaele

Milan, Italy, 20132

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Clinical characteristics 1

Time frame: 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 2

Time frame: 2 YEARS

to correlate treatment strategy with survival end-points
Clinical characteristics 3

Time frame: 2 YEARS

to evaluate the Progression Free Survical ( PFS) after CNS events
Clinical characteristics 4

Time frame: 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

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Official study title

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

Important dates

Study start: 2022
Primary completion: 2026
Study completion: 2027
First posted: Sep 6, 2023
Registry last updated: Jun 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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