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

Primary Mediastinal Large B-cell Lymphoma (PMBCL) Clinical Trial

Official 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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05856708
• Other study ID #: OSR- PMLBCL SNC+
• Status: Active, not recruiting
• Start date: January 2003
• Est. completion date: December 2024

Study information

• Verified date: September 2023
• Source: IRCCS San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 45
• Est. completion date: December 2024
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, B-Cell
• Primary Mediastinal Large B-cell Lymphoma (PMBCL)

Intervention

Other:
• DISEASE

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Raffaele

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PT CHARACTERISTICS	to describe the PMLBCL characteristics at diagnosis and at CNS relapse ( first relapse or second and subsequent recurrences) and the treatment received	2003-2020
Primary	CNS RELAPSE	to describe the median time to CNS relapse	2003-2020
Primary	PROGNOSTIC FACTORS	to define prognostic factors of outcome of CNS relapse in PMLBCL patients	2003-2020
Primary	TREATMENT STRATEGY	to correlate treatment strategy with survival end-points	2003-2020
Primary	PFS	to evaluate the Progression Free Survical ( PFS) after CNS events	2003-2020
Primary	OS	to evaluate Overall Survival ( OS) after CNS relapse	2003-2020
Primary	MOLECULAR DIAGNOSTIC	to central pathological reviewed the initial diagnosis and the relapse and to correlate biological and molecular factors with CNS recurrence	2003-2020