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

May 29, 2026 updated by: Fondazione Italiana Linfomi - ETS

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

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).

Study Overview

Status

Completed

Conditions

Detailed 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)

Study Type

Observational

Enrollment (Actual)

633

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Alessandria, Italy, 15121
        • SC Ematologia, A.O. SS. Antonio e Biagio e Cesare Arrigo
      • Ancona, Italy, 60126
        • Clinica di Ematologia, AOU Ospedali Riuniti
      • Avellino, Italy, 83100
        • Azienda Ospedaliera S.Giuseppe Moscati - S.C. Ematologia e Trapianto emopoietico
      • Aviano, Italy, 33081
        • Divisione di Oncologia e dei Tumori immuno-correlati, IRCCS Centro di Riferimento Oncologico di Aviano
      • Bari, Italy, 70124
        • U.O. Ematologia con Trapianto, AOU Policlinico Consorziale
      • Bari, Italy, 70124
        • U.O.C. Ematologia - IRCCS Istituto Tumori Giovanni Paolo II
      • Barletta, Italy, 76121
        • Ematologia, Ospedale "Monsignor Raffaele Dimiccoli"
      • Bologna, Italy, 40138
        • Istituto di Ematologia "Seragnoli", Policlinico S.Orsola-Malpighi
      • Brescia, Italy, 25123
        • Ematologia, ASST Spedali Civili di Brescia
      • Brindisi, Italy, 72100
        • U.O. Ematologia e Trapianti di Midollo, Ospedale Antonio Perrino
      • Cagliari, Italy, 09121
        • SC Ematologia e CTMO, Ospedale Businco
      • Catania, Italy, 95122
        • Arnas Nuovo Ospedale Garibaldi Nesima
      • Catania, Italy, 95124
        • Ematologia, Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele Presidio Ospedale Ferrarotto
      • Cosenza, Italy, 87100
        • UOC Ematologia, Azienda Ospedaliera di Cosenza
      • Florence, Italy, 50141
        • Unitа funzionale di Ematologia, Azienda Ospedaliera Universitaria Careggi
      • Lecce, Italy, 73100
        • Ematologia, Ospedale Vito Fazzi
      • Matera, Italy, 75100
        • Ematologia, Ospedale Madonna delle Grazie
      • Messina, Italy, 98158
        • SC Ematologia, Azienda Ospedali Riuniti Papardo-Piemonte
      • Milan, Italy, 20133
        • Ematologia, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano
      • Milan, Italy, 20141
        • Divisione Ematoncologia, IEO Istitito Europeo di Oncologia
      • Milan, Italy, 20162
        • SC Ematologia, ASST Grande Ospedale Metropolitano Niguarda
      • Naples, Italy, 80131
        • UOC Ematologia Oncologica, Istituto Nazionale Tumori - IRCCS Fondazione G. Pascale
      • Padova, Italy, 35128
        • Istituto Oncologico Veneto I.R.C.C.S.
      • Palermo, Italy, 90127
        • Ematologia, AOU Policlinico Giaccone
      • Palermo, Italy, 90146
        • Divisione di Ematologia, A.O. Ospedali Riuniti Villa Sofia-Cervello
      • Palermo, Italy, 90146
        • Oncoematologia e TMO Dip. Oncologia, Casa di Cura La Maddalena
      • Pisa, Italy, 56126
        • Azienda Ospedaliera Universitaria Pisana - U.O. Ematologia
      • Reggio Calabria, Italy, 89124
        • Ematologia, Grande Ospedale Metropolitano Bianchi Melacrino Morelli
      • Reggio Emilia, Italy, 42123
        • Ematologia, Azienda Unitа Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova
      • Roma, Italy, 00152
        • Ematologia, Ospedale S. Camillo
      • Roma, Italy, 00161
        • Istituto Ematologia -Dipartimento di Medicina Traslazionale e di Precisione,Policlinico Umberto I - Universitа "La Sapienza"
      • Roma, Italy, 00168
        • Ematologia, Universitа Cattolica S. Cuore
      • Rozzano, Italy, 20089
        • UO Ematologia, Istituto Clinico Humanitas
      • San Giovanni Rotondo, Italy, 71013
        • UO Ematologia, Casa Sollievo della Sofferenza
      • Taranto, Italy, 74010
        • SC Ematologia, Ospedale "S.G. Moscati"
      • Terni, Italy, 05100
        • Azienda Ospedaliera Santa Maria - S.C. Oncoematologia
      • Torino, Italy, 10126
        • Ematologia Universitaria, A.O.U. Citta della Salute e della Scienza di Torino
      • Torino, Italy, 10126
        • SC Ematologia, A.O.U. Citta della Salute e della Scienza di Torino
      • Verona, Italy, 37134
        • UO Ematologia, AOU Integrata di Verona
    • Catania
      • Viagrande, Catania, Italy, 95029
        • U.F. Oncoematologia, IOM (Istituto Oncologico del Mediterraneo)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients newly diagnosed with PMBCL between 01 January 2007 and 31 December 2019 attending participating centres.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Primary Mediastinal large B-Cell Lymphoma (PMBCL)
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?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
The endpoint will be evaluated from the beginning to the end of the study (up to 24 months)
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
The endpoint will be evaluated from the beginning to the end of the study (up to 24 months)
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
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
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
four months after completion of chemotherapy
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.
The endpoint will be evaluated from the beginning to the end of the study (up to 24 months)
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.
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
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)
The endpoint will be evaluated from the beginning to the end of the study (up to 24 months)
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)
The endpoint will be evaluated from the beginning to the end of the study (up to 24 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Italiana Linfomi - ETS

Investigators

  • Principal Investigator: Ugo Consoli, U.O.C Ematologia, ARNAS Garibaldi; P.O. Garibaldi - Nesima, Catania.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 2, 2019

Primary Completion (Actual)

December 5, 2022

Study Completion (Actual)

July 11, 2025

Study Registration Dates

First Submitted

November 26, 2021

First Submitted That Met QC Criteria

December 16, 2021

First Posted (Actual)

December 17, 2021

Study Record Updates

Last Update Posted (Actual)

June 1, 2026

Last Update Submitted That Met QC Criteria

May 29, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FIL_PMBCL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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