Primary Mediastinal Large B-cell Lymphoma (PMBCL): Multicenter Retrospective Study

  • STATUS
    Recruiting
  • End date
    Sep 21, 2023
  • participants needed
    400
  • sponsor
    Fondazione Italiana Linfomi ONLUS
Updated on 19 June 2022

Summary

The present study consists of a retrospective multicentric collection of all consecutive patients with PMBCL diagnosed over the time period considered (13 years, from 2007 to 2019 inclusive).

Description

The study was initially set up as a spontaneous, non-profit study, with ARNAS Garibaldi of Catania (PI Dr Ugo Consoli) as the proposer. Subsequently, the project was expanded to include additional centres belonging to the Italian Lymphoma Foundation, which became the promoter in collaboration with ARNAS Garibaldi of Catania. The information collected is aimed at verifying the application in a "real world" context of the PMBCL diagnosis and therapy protocols suggested in the guidelines and at checking whether they produce results in line with those expected.

The therapies considered for the I line of treatment are those described in the literature for the pathology under consideration:

  • R-CHOP14; R-CHOP21 and R-CHOP like, (R-CHOP: rituximab - cyclophosphamide, doxorubicin, vincristine, prednisone)
  • R-VACOPB, R-MACOPB and R-VACOPB like, MACOPB like, (R-VACOP-B: Rituximab - etoposide, doxorubicin, cyclophosphamide, vincristine, prednisone, bleomycin. R-MACOP-B: Rituximab
  • methotrexate, doxorubicin, cyclophosphamide, vincristine, prednisone, bleomycin)
  • R-DA-EPOCH ed R-EPOCH like (DA-R- EPOCH: Dose Adjusted - Rituximab - Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin)

Details
Condition Primary Mediastinal Large B-cell Lymphoma (PMBCL)
Clinical Study IdentifierNCT05162170
SponsorFondazione Italiana Linfomi ONLUS
Last Modified on19 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

All consecutive patients treated in the centre during the period considered
Age>=18 years
Histological diagnosis of PMBCL
Signature of "Informed Consent" to participate in the study (if applicable)
Treatment according to local practice
Diagnosis between 01 January 2007 and 31 December 2019

Exclusion Criteria

The exclusion criteria, being an observational study, are focused and limited to excluding cases with a non-compliant histological diagnosis
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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