Primary Mediastinal Large B-cell Lymphoma With CNS Involvement

Sponsor
IRCCS San Raffaele (Other)
Overall Status
Recruiting
CT.gov ID
NCT06024694
Collaborator
(none)
45
1
24
1.9

Study Details

Study Description

Brief Summary

retrospective 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    45 participants
    Observational Model:
    Other
    Time Perspective:
    Retrospective
    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
    Actual Study Start Date :
    Jun 10, 2022
    Anticipated Primary Completion Date :
    Jun 10, 2024
    Anticipated Study Completion Date :
    Jun 10, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    patients diagnosed with PMLBL

    Patients whose diagnosis met the histological criteria of PMLBL according WHO classification with a diagnosis of CNS involvement at relapse/progression

    Outcome Measures

    Primary Outcome Measures

    1. Clinical characteristics 1 [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

    2. Clinical characteristics 2 [2 YEARS]

      to correlate treatment strategy with survival end-points

    3. Clinical characteristics 3 [2 YEARS]

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

    4. Clinical characteristics 4 [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ospedale San Raffaele Milan Italy 20132

    Sponsors and Collaborators

    • IRCCS San Raffaele

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Andrés José Maria Ferreri, Lymphoma Unit Director, IRCCS San Raffaele
    ClinicalTrials.gov Identifier:
    NCT06024694
    Other Study ID Numbers:
    • Observational Retrospective
    First Posted:
    Sep 6, 2023
    Last Update Posted:
    Sep 6, 2023
    Last Verified:
    Aug 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Andrés José Maria Ferreri, Lymphoma Unit Director, IRCCS San Raffaele
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 6, 2023