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

NCT ID: NCT05162170

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

633 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-02

Study Completion Date

2025-07-11

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)

Conditions

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Primary Mediastinal Large B-cell Lymphoma (PMBCL)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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).

No interventions assigned to this group

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione Italiana Linfomi - ETS

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ugo Consoli

Role: PRINCIPAL_INVESTIGATOR

U.O.C Ematologia, ARNAS Garibaldi; P.O. Garibaldi - Nesima, Catania.

Locations

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

Viagrande, Catania, Italy

Site Status

SC Ematologia, A.O. SS. Antonio e Biagio e Cesare Arrigo

Alessandria, , Italy

Site Status

Clinica di Ematologia, AOU Ospedali Riuniti

Ancona, , Italy

Site Status

Azienda Ospedaliera S.Giuseppe Moscati - S.C. Ematologia e Trapianto emopoietico

Avellino, , Italy

Site Status

Divisione di Oncologia e dei Tumori immuno-correlati, IRCCS Centro di Riferimento Oncologico di Aviano

Aviano, , Italy

Site Status

U.O. Ematologia con Trapianto, AOU Policlinico Consorziale

Bari, , Italy

Site Status

U.O.C. Ematologia - IRCCS Istituto Tumori Giovanni Paolo II

Bari, , Italy

Site Status

Ematologia, Ospedale "Monsignor Raffaele Dimiccoli"

Barletta, , Italy

Site Status

Istituto di Ematologia "Seragnoli", Policlinico S.Orsola-Malpighi

Bologna, , Italy

Site Status

Ematologia, ASST Spedali Civili di Brescia

Brescia, , Italy

Site Status

U.O. Ematologia e Trapianti di Midollo, Ospedale Antonio Perrino

Brindisi, , Italy

Site Status

SC Ematologia e CTMO, Ospedale Businco

Cagliari, , Italy

Site Status

Arnas Nuovo Ospedale Garibaldi Nesima

Catania, , Italy

Site Status

Ematologia, Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele Presidio Ospedale Ferrarotto

Catania, , Italy

Site Status

UOC Ematologia, Azienda Ospedaliera di Cosenza

Cosenza, , Italy

Site Status

Unitа funzionale di Ematologia, Azienda Ospedaliera Universitaria Careggi

Florence, , Italy

Site Status

Ematologia, Ospedale Vito Fazzi

Lecce, , Italy

Site Status

Ematologia, Ospedale Madonna delle Grazie

Matera, , Italy

Site Status

SC Ematologia, Azienda Ospedali Riuniti Papardo-Piemonte

Messina, , Italy

Site Status

Ematologia, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano

Milan, , Italy

Site Status

Divisione Ematoncologia, IEO Istitito Europeo di Oncologia

Milan, , Italy

Site Status

SC Ematologia, ASST Grande Ospedale Metropolitano Niguarda

Milan, , Italy

Site Status

UOC Ematologia Oncologica, Istituto Nazionale Tumori - IRCCS Fondazione G. Pascale

Napoli, , Italy

Site Status

Istituto Oncologico Veneto I.R.C.C.S.

Padua, , Italy

Site Status

Ematologia, AOU Policlinico Giaccone

Palermo, , Italy

Site Status

Divisione di Ematologia, A.O. Ospedali Riuniti Villa Sofia-Cervello

Palermo, , Italy

Site Status

Oncoematologia e TMO Dip. Oncologia, Casa di Cura La Maddalena

Palermo, , Italy

Site Status

Azienda Ospedaliera Universitaria Pisana - U.O. Ematologia

Pisa, , Italy

Site Status

Ematologia, Grande Ospedale Metropolitano Bianchi Melacrino Morelli

Reggio Calabria, , Italy

Site Status

Ematologia, Azienda Unitа Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova

Reggio Emilia, , Italy

Site Status

Ematologia, Ospedale S. Camillo

Roma, , Italy

Site Status

Istituto Ematologia -Dipartimento di Medicina Traslazionale e di Precisione,Policlinico Umberto I - Universitа "La Sapienza"

Roma, , Italy

Site Status

Ematologia, Universitа Cattolica S. Cuore

Roma, , Italy

Site Status

UO Ematologia, Istituto Clinico Humanitas

Rozzano, , Italy

Site Status

UO Ematologia, Casa Sollievo della Sofferenza

San Giovanni Rotondo, , Italy

Site Status

SC Ematologia, Ospedale "S.G. Moscati"

Taranto, , Italy

Site Status

Azienda Ospedaliera Santa Maria - S.C. Oncoematologia

Terni, , Italy

Site Status

Ematologia Universitaria, A.O.U. Citta della Salute e della Scienza di Torino

Torino, , Italy

Site Status

SC Ematologia, A.O.U. Citta della Salute e della Scienza di Torino

Torino, , Italy

Site Status

UO Ematologia, AOU Integrata di Verona

Verona, , Italy

Site Status

Countries

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Italy

Other Identifiers

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FIL_PMBCL

Identifier Type: -

Identifier Source: org_study_id