CNS Involvement in Primary Mediastinal Large B-Cell Lymphoma (PMLBCL)

May 5, 2025 updated by: Andrés José Maria Ferreri, IRCCS San Raffaele

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.

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy, 20132
        • IRCCS Ospedale San Raffaele

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2003-2020
CNS RELAPSE
Time Frame: 2003-2020
to describe the median time to CNS relapse
2003-2020
PROGNOSTIC FACTORS
Time Frame: 2003-2020
to define prognostic factors of outcome of CNS relapse in PMLBCL patients
2003-2020
TREATMENT STRATEGY
Time Frame: 2003-2020
to correlate treatment strategy with survival end-points
2003-2020
PFS
Time Frame: 2003-2020
to evaluate the Progression Free Survical ( PFS) after CNS events
2003-2020
OS
Time Frame: 2003-2020
to evaluate Overall Survival ( OS) after CNS relapse
2003-2020
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
2003-2020

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS San Raffaele

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 30, 2022

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 30, 2027

Study Registration Dates

First Submitted

May 4, 2023

First Submitted That Met QC Criteria

May 4, 2023

First Posted (Actual)

May 12, 2023

Study Record Updates

Last Update Posted (Actual)

May 7, 2025

Last Update Submitted That Met QC Criteria

May 5, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OSR- PMLBCL SNC+

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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