Clinical trial NCT05162170: Primary Mediastinal Large B-cell Lymphoma (PMBCL): Multicenter Retrospective Study
Official title: Primary Mediastinal Large B-cell Lymphoma (PMBCL): Multicenter Retrospective Study by the Fondazione Italiana Linfomi.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Primary Mediastinal Large B-cell Lymphoma (PMBCL)
Lead sponsor: Fondazione Italiana Linfomi - ETS
Sponsor class: OTHER
First posted: 2021-12-17
Enrollment: 633
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients newly diagnosed with PMBCL between 01 January 2007 and 31 December 2019 attending participating centres.

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).

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)

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of primary/early refractory disease
timeFrame: The endpoint will be evaluated from the beginning to the end of the study (up to 24 months)
measure: Overall response rate (ORR)
timeFrame: The endpoint will be evaluated from the beginning to the end of the study (up to 24 months)
measure: Complete response rate (CRR)
timeFrame: The endpoint will be evaluated from the beginning to the end of the study (up to 24 months)
measure: Frequency of administration of mediastinal radiation therapy
timeFrame: four months after completion of chemotherapy
measure: Progression Free Survival (PFS)
timeFrame: The endpoint will be evaluated from the beginning to the end of the study (up to 24 months)
measure: Overall Survival (OS)
timeFrame: The endpoint will be evaluated from the beginning to the end of the study (up to 24 months)
Secondary outcomes:
measure: Acute toxicity
timeFrame: The endpoint will be evaluated from the beginning to the end of the study (up to 24 months)
measure: Long-term toxicity
timeFrame: The endpoint will be evaluated from the beginning to the end of the study (up to 24 months)
Other outcomes:
Locations:
city: Viagrande
country: Italy
facility: U.F. Oncoematologia, IOM (Istituto Oncologico del Mediterraneo)
state: Catania
city: Alessandria
country: Italy
facility: SC Ematologia, A.O. SS. Antonio e Biagio e Cesare Arrigo
city: Ancona
country: Italy
facility: Clinica di Ematologia, AOU Ospedali Riuniti
city: Avellino
country: Italy
facility: Azienda Ospedaliera S.Giuseppe Moscati - S.C. Ematologia e Trapianto emopoietico
city: Aviano
country: Italy
facility: Divisione di Oncologia e dei Tumori immuno-correlati, IRCCS Centro di Riferimento Oncologico di Aviano
city: Bari
country: Italy
facility: U.O. Ematologia con Trapianto, AOU Policlinico Consorziale
city: Bari
country: Italy
facility: U.O.C. Ematologia - IRCCS Istituto Tumori Giovanni Paolo II
city: Barletta
country: Italy
facility: Ematologia, Ospedale "Monsignor Raffaele Dimiccoli"
city: Bologna
country: Italy
facility: Istituto di Ematologia "Seragnoli", Policlinico S.Orsola-Malpighi
city: Brescia
country: Italy
facility: Ematologia, ASST Spedali Civili di Brescia
city: Brindisi
country: Italy
facility: U.O. Ematologia e Trapianti di Midollo, Ospedale Antonio Perrino
city: Cagliari
country: Italy
facility: SC Ematologia e CTMO, Ospedale Businco
city: Catania
country: Italy
facility: Arnas Nuovo Ospedale Garibaldi Nesima
city: Catania
country: Italy
facility: Ematologia, Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele Presidio Ospedale Ferrarotto
city: Cosenza
country: Italy
facility: UOC Ematologia, Azienda Ospedaliera di Cosenza
city: Firenze
country: Italy
facility: Unitа funzionale di Ematologia, Azienda Ospedaliera Universitaria Careggi
city: Lecce
country: Italy
facility: Ematologia, Ospedale Vito Fazzi
city: Matera
country: Italy
facility: Ematologia, Ospedale Madonna delle Grazie
city: Messina
country: Italy
facility: SC Ematologia, Azienda Ospedali Riuniti Papardo-Piemonte
city: Milano
country: Italy
facility: Ematologia, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano
city: Milano
country: Italy
facility: Divisione Ematoncologia, IEO Istitito Europeo di Oncologia
city: Milano
country: Italy
facility: SC Ematologia, ASST Grande Ospedale Metropolitano Niguarda
city: Napoli
country: Italy
facility: UOC Ematologia Oncologica, Istituto Nazionale Tumori - IRCCS Fondazione G. Pascale
city: Padova
country: Italy
facility: Istituto Oncologico Veneto I.R.C.C.S.
city: Palermo
country: Italy
facility: Ematologia, AOU Policlinico Giaccone
city: Palermo
country: Italy
facility: Divisione di Ematologia, A.O. Ospedali Riuniti Villa Sofia-Cervello
city: Palermo
country: Italy
facility: Oncoematologia e TMO Dip. Oncologia, Casa di Cura La Maddalena
city: Pisa
country: Italy
facility: Azienda Ospedaliera Universitaria Pisana - U.O. Ematologia
city: Reggio Calabria
country: Italy
facility: Ematologia, Grande Ospedale Metropolitano Bianchi Melacrino Morelli
city: Reggio Emilia
country: Italy
facility: Ematologia, Azienda Unitа Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova
city: Roma
country: Italy
facility: Ematologia, Ospedale S. Camillo
city: Roma
country: Italy
facility: Istituto Ematologia -Dipartimento di Medicina Traslazionale e di Precisione,Policlinico Umberto I - Universitа "La Sapienza"
city: Roma
country: Italy
facility: Ematologia, Universitа Cattolica S. Cuore
city: Rozzano
country: Italy
facility: UO Ematologia, Istituto Clinico Humanitas
city: San Giovanni Rotondo
country: Italy
facility: UO Ematologia, Casa Sollievo della Sofferenza
city: Taranto
country: Italy
facility: SC Ematologia, Ospedale "S.G. Moscati"
city: Terni
country: Italy
facility: Azienda Ospedaliera Santa Maria - S.C. Oncoematologia
city: Torino
country: Italy
facility: Ematologia Universitaria, A.O.U. Citta della Salute e della Scienza di Torino
city: Torino
country: Italy
facility: SC Ematologia, A.O.U. Citta della Salute e della Scienza di Torino
city: Verona
country: Italy
facility: UO Ematologia, AOU Integrata di Verona
Study officials:
affiliation: U.O.C Ematologia, ARNAS Garibaldi; P.O. Garibaldi - Nesima, Catania.
name: Ugo Consoli
role: PRINCIPAL_INVESTIGATOR
References: