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NCT Number: NCT05162170

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

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).

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Key information

Conditions

Primary Mediastinal Large B-cell Lymphoma (PMBCL)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

U.F. Oncoematologia, IOM (Istituto Oncologico del Mediterraneo), Viagrande, Catania, Italy

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About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Rate of primary/early refractory disease

    Time frame: The endpoint will be evaluated from the beginning to the end of the study (up to 24 months)

    The study aims to evaluate the rate of primary/early refractory disease (Primary mediastinal large B-cell lymphoma)

  2. Overall response rate (ORR)

    Time frame: The endpoint will be evaluated from the beginning to the end of the study (up to 24 months)

    Overall Response Rate is defined as the percentage of patients in complete remission or in partial remission

  3. Complete response rate (CRR)

    Time frame: The endpoint will be evaluated from the beginning to the end of the study (up to 24 months)

    The Complete Response Rate is defined as the percentage of patient in Complete Remission

  4. Frequency of administration of mediastinal radiation therapy

    Time frame: four months after completion of chemotherapy

    Analyze the frequency of administration of mediastinal radiation therapy in patients affected by primary mediastinal large B-cell lymphoma

  5. Progression Free Survival (PFS)

    Time frame: The endpoint will be evaluated from the beginning to the end of the study (up to 24 months)

    The length of time during and after the treatment that patients live with the disease, but it does not get worse. Progression-Free Survival (PFS) will be defined from the date of starting therapy and the date of disease progression, relapse or death from any cause.

  6. Overall Survival (OS)

    Time frame: The endpoint will be evaluated from the beginning to the end of the study (up to 24 months)

    Overall Survival, the percentage of patients alive, is defined from the start date of therapy to the date of death from any cause.

Secondary outcomes

  1. Acute toxicity

    Time frame: The endpoint will be evaluated from the beginning to the end of the study (up to 24 months)

    Analyze incidence and type of acute toxicity (haematological and extra haematological toxicity)

  2. Long-term toxicity

    Time frame: The endpoint will be evaluated from the beginning to the end of the study (up to 24 months)

    Analyze incidence and type of long-term toxicity (cardiological toxicity and second tumors)

Sponsors and collaborators

Lead sponsor

Fondazione Italiana Linfomi - ETS

Other

Registry information

Official study title

Primary Mediastinal Large B-cell Lymphoma (PMBCL): Multicenter Retrospective Study by the Fondazione Italiana Linfomi.

Important dates

Study start
2019
Primary completion
2022
Study completion
2025
First posted
Dec 17, 2021
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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