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

Study Overview
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Brief Summary
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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).

Detailed Description
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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)

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

Conditions
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Primary Mediastinal Large B-cell Lymphoma (PMBCL)

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Primary Mediastinal large B-Cell Lymphoma (PMBCL)<br>The present study consists of a retrospective multicenter collection of series of consecutive patients diagnosed with PMBCL over the relevant time period (13 years, from 2007 to 2019 included). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of primary/early refractory disease | The study aims to evaluate the rate of primary/early refractory disease (Primary mediastinal large B-cell lymphoma) | The endpoint will be evaluated from the beginning to the end of the study (up to 24 months) | 
| Overall response rate (ORR) | Overall Response Rate is defined as the percentage of patients in complete remission or in partial remission | The endpoint will be evaluated from the beginning to the end of the study (up to 24 months) | 
| Complete response rate (CRR) | The Complete Response Rate is defined as the percentage of patient in Complete Remission | The endpoint will be evaluated from the beginning to the end of the study (up to 24 months) | 
| Frequency of administration of mediastinal radiation therapy | Analyze the frequency of administration of mediastinal radiation therapy in patients affected by primary mediastinal large B-cell lymphoma | four months after completion of chemotherapy | 
| Progression Free Survival (PFS) | 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. | The endpoint will be evaluated from the beginning to the end of the study (up to 24 months) | 
| Overall Survival (OS) | Overall Survival, the percentage of patients alive, is defined from the start date of therapy to the date of death from any cause. | The endpoint will be evaluated from the beginning to the end of the study (up to 24 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute toxicity | Analyze incidence and type of acute toxicity (haematological and extra haematological toxicity) | The endpoint will be evaluated from the beginning to the end of the study (up to 24 months) | 
| Long-term toxicity | Analyze incidence and type of long-term toxicity (cardiological toxicity and second tumors) | The endpoint will be evaluated from the beginning to the end of the study (up to 24 months) |