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

Active, not recruiting

• Conditions: Primary Mediastinal Large B-cell Lymphoma (PMBCL)

• Registration Number: NCT05856708
• Lead Sponsor: IRCCS San Raffaele

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-30
• Study First Submitted: 2023-05-04
• Study First Submitted QC: 2023-05-04
• Study First Posted: 2023-05-12
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-05
• Last Update Posted: 2025-05-07
• Primary Completion: 2026-12-30
• Study Completion: 2027-12-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 45

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
TREATMENT STRATEGY	2003-2020	to correlate treatment strategy with survival end-points
OS	2003-2020	to evaluate Overall Survival ( OS) after CNS relapse
MOLECULAR DIAGNOSTIC	2003-2020	to central pathological reviewed the initial diagnosis and the relapse and to correlate biological and molecular factors with CNS recurrence
CNS RELAPSE	2003-2020	to describe the median time to CNS relapse
PT CHARACTERISTICS	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	2003-2020	to define prognostic factors of outcome of CNS relapse in PMLBCL patients
PFS	2003-2020	to evaluate the Progression Free Survical ( PFS) after CNS events

Trial Locations

Locations (1)

IRCCS Ospedale San Raffaele; 🇮🇹 Milan, Italy