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

NCT05162170 | Completed

• 1 other identifier: FIL_PMBCL
• Study Type: observational
• Target: 633
• Locations: 1 country
• Sites: 40

Brief 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).

Conditions

Primary Mediastinal Large B-cell Lymphoma (PMBCL)

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (2)

• Acute toxicity

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

• Long-term toxicity

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

Study Arms (1)

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

Sponsors & Collaborators

• Fondazione Italiana Linfomi - ETS: lead

Study Sites (40)

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

Viagrande, Catania, 95029, Italy

Location

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

Alessandria, 15121, Italy

Location

Clinica di Ematologia, AOU Ospedali Riuniti

Ancona, 60126, Italy

Location

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

Avellino, 83100, Italy

Location

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

Aviano, 33081, Italy

Location

U.O. Ematologia con Trapianto, AOU Policlinico Consorziale

Bari, 70124, Italy

Location

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

Bari, 70124, Italy

Location

Ematologia, Ospedale "Monsignor Raffaele Dimiccoli"

Barletta, 76121, Italy

Location

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

Bologna, 40138, Italy

Location

Ematologia, ASST Spedali Civili di Brescia

Brescia, 25123, Italy

Location

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

Brindisi, 72100, Italy

Location

SC Ematologia e CTMO, Ospedale Businco

Cagliari, 09121, Italy

Location

Arnas Nuovo Ospedale Garibaldi Nesima

Catania, 95122, Italy

Location

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

Catania, 95124, Italy

Location

UOC Ematologia, Azienda Ospedaliera di Cosenza

Cosenza, 87100, Italy

Location

Unitа funzionale di Ematologia, Azienda Ospedaliera Universitaria Careggi

Florence, 50141, Italy

Location

Ematologia, Ospedale Vito Fazzi

Lecce, 73100, Italy

Location

Ematologia, Ospedale Madonna delle Grazie

Matera, 75100, Italy

Location

SC Ematologia, Azienda Ospedali Riuniti Papardo-Piemonte

Messina, 98158, Italy

Location

Ematologia, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano

Milan, 20133, Italy

Location

Divisione Ematoncologia, IEO Istitito Europeo di Oncologia

Milan, 20141, Italy

Location

SC Ematologia, ASST Grande Ospedale Metropolitano Niguarda

Milan, 20162, Italy

Location

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

Naples, 80131, Italy

Location

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

Padua, 35128, Italy

Location

Ematologia, AOU Policlinico Giaccone

Palermo, 90127, Italy

Location

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

Palermo, 90146, Italy

Location

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

Palermo, 90146, Italy

Location

Azienda Ospedaliera Universitaria Pisana - U.O. Ematologia

Pisa, 56126, Italy

Location

Ematologia, Grande Ospedale Metropolitano Bianchi Melacrino Morelli

Reggio Calabria, 89124, Italy

Location

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

Reggio Emilia, 42123, Italy

Location

Ematologia, Ospedale S. Camillo

Roma, 00152, Italy

Location

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

Roma, 00161, Italy

Location

Ematologia, Universitа Cattolica S. Cuore

Roma, 00168, Italy

Location

UO Ematologia, Istituto Clinico Humanitas

Rozzano, 20089, Italy

Location

UO Ematologia, Casa Sollievo della Sofferenza

San Giovanni Rotondo, 71013, Italy

Location

SC Ematologia, Ospedale "S.G. Moscati"

Taranto, 74010, Italy

Location

Azienda Ospedaliera Santa Maria - S.C. Oncoematologia

Terni, 05100, Italy

Location

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

Torino, 10126, Italy

Location

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

Torino, 10126, Italy

Location

UO Ematologia, AOU Integrata di Verona

Verona, 37134, Italy

Location

Study Officials

• Ugo Consoli

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2021
• First Posted: December 17, 2021
• Study Start: October 2, 2019
• Primary Completion: December 5, 2022
• Study Completion: July 11, 2025
• Last Updated: December 24, 2025

Record last verified: 2025-12

Locations

IT (40)