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

Sponsor
Andrés José Maria Ferreri (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05856708
Collaborator
(none)
45
Enrollment
263
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: DISEASE

Study Design

Study Type:
Observational
Actual Enrollment :
45 participants
Observational Model:
Cohort
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 :
Jan 1, 2003
Actual Primary Completion Date :
Dec 1, 2020
Anticipated Study Completion Date :
Dec 1, 2024

Outcome Measures

Primary Outcome Measures

  1. 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

  2. CNS RELAPSE [2003-2020]

    to describe the median time to CNS relapse

  3. PROGNOSTIC FACTORS [2003-2020]

    to define prognostic factors of outcome of CNS relapse in PMLBCL patients

  4. TREATMENT STRATEGY [2003-2020]

    to correlate treatment strategy with survival end-points

  5. PFS [2003-2020]

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

  6. OS [2003-2020]

    to evaluate Overall Survival ( OS) after CNS relapse

  7. MOLECULAR DIAGNOSTIC [2003-2020]

    to central 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 and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Andrés José Maria Ferreri

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Andrés José Maria Ferreri, MD, IRCCS San Raffaele
ClinicalTrials.gov Identifier:
NCT05856708
Other Study ID Numbers:
  • OSR- PMLBCL SNC+
First Posted:
May 12, 2023
Last Update Posted:
May 12, 2023
Last Verified:
May 1, 2023
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, MD, IRCCS San Raffaele
PMLBCL
CNS
Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell

Study Results

No Results Posted as of May 12, 2023