Primary Mediastinal Large B-cell Lymphoma (PMBCL): Multicenter Retrospective Study
- Conditions
- Primary Mediastinal Large B-cell Lymphoma (PMBCL)
- Registration Number
- NCT05162170
- Lead Sponsor
- Fondazione Italiana Linfomi - ETS
- 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)
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 633
- 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
- The exclusion criteria, being an observational study, are focused and limited to excluding cases with a non-compliant histological diagnosis.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall response rate (ORR) 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
Frequency of administration of mediastinal radiation therapy 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
Overall Survival (OS) 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.
Progression Free Survival (PFS) 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.
Rate of primary/early refractory disease 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)
Complete response rate (CRR) 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
- Secondary Outcome Measures
Name Time Method Acute toxicity 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)
Long-term toxicity 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)
Trial Locations
- Locations (40)
Azienda Ospedaliera S.Giuseppe Moscati - S.C. Ematologia e Trapianto emopoietico
๐ฎ๐นAvellino, Italy
U.F. Oncoematologia, IOM (Istituto Oncologico del Mediterraneo)
๐ฎ๐นViagrande, Catania, Italy
SC Ematologia, A.O. SS. Antonio e Biagio e Cesare Arrigo
๐ฎ๐นAlessandria, Italy
Clinica di Ematologia, AOU Ospedali Riuniti
๐ฎ๐นAncona, Italy
Divisione di Oncologia e dei Tumori immuno-correlati, IRCCS Centro di Riferimento Oncologico di Aviano
๐ฎ๐นAviano, Italy
U.O. Ematologia con Trapianto, AOU Policlinico Consorziale
๐ฎ๐นBari, Italy
Ematologia, Ospedale Vito Fazzi
๐ฎ๐นLecce, Italy
U.O.C. Ematologia - IRCCS Istituto Tumori Giovanni Paolo II
๐ฎ๐นBari, Italy
U.O. Ematologia e Trapianti di Midollo, Ospedale Antonio Perrino
๐ฎ๐นBrindisi, Italy
Istituto di Ematologia "Seragnoli", Policlinico S.Orsola-Malpighi
๐ฎ๐นBologna, Italy
Ematologia, ASST Spedali Civili di Brescia
๐ฎ๐นBrescia, Italy
SC Ematologia e CTMO, Ospedale Businco
๐ฎ๐นCagliari, Italy
UOC Ematologia, Azienda Ospedaliera di Cosenza
๐ฎ๐นCosenza, Italy
Unitะฐ funzionale di Ematologia, Azienda Ospedaliera Universitaria Careggi
๐ฎ๐นFirenze, Italy
Arnas Nuovo Ospedale Garibaldi Nesima
๐ฎ๐นCatania, Italy
Ematologia, Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele Presidio Ospedale Ferrarotto
๐ฎ๐นCatania, Italy
Ematologia, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano
๐ฎ๐นMilano, Italy
Ematologia, Ospedale Madonna delle Grazie
๐ฎ๐นMatera, Italy
SC Ematologia, Azienda Ospedali Riuniti Papardo-Piemonte
๐ฎ๐นMessina, Italy
Divisione Ematoncologia, IEO Istitito Europeo di Oncologia
๐ฎ๐นMilano, Italy
SC Ematologia, ASST Grande Ospedale Metropolitano Niguarda
๐ฎ๐นMilano, Italy
UOC Ematologia Oncologica, Istituto Nazionale Tumori - IRCCS Fondazione G. Pascale
๐ฎ๐นNapoli, Italy
Istituto Oncologico Veneto I.R.C.C.S.
๐ฎ๐นPadova, Italy
Oncoematologia e TMO Dip. Oncologia, Casa di Cura La Maddalena
๐ฎ๐นPalermo, Italy
Ematologia, AOU Policlinico Giaccone
๐ฎ๐นPalermo, Italy
Azienda Ospedaliera Universitaria Pisana - U.O. Ematologia
๐ฎ๐นPisa, Italy
Ematologia, Grande Ospedale Metropolitano Bianchi Melacrino Morelli
๐ฎ๐นReggio Calabria, Italy
Ematologia, Azienda Unitะฐ Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova
๐ฎ๐นReggio Emilia, Italy
Ematologia, Ospedale S. Camillo
๐ฎ๐นRoma, Italy
Istituto Ematologia -Dipartimento di Medicina Traslazionale e di Precisione,Policlinico Umberto I - Universitะฐ "La Sapienza"
๐ฎ๐นRoma, Italy
Ematologia, Universitะฐ Cattolica S. Cuore
๐ฎ๐นRoma, Italy
UO Ematologia, Casa Sollievo della Sofferenza
๐ฎ๐นSan Giovanni Rotondo, Italy
SC Ematologia, Ospedale "S.G. Moscati"
๐ฎ๐นTaranto, Italy
Azienda Ospedaliera Santa Maria - S.C. Oncoematologia
๐ฎ๐นTerni, Italy
Ematologia Universitaria, A.O.U. Citta della Salute e della Scienza di Torino
๐ฎ๐นTorino, Italy
SC Ematologia, A.O.U. Citta della Salute e della Scienza di Torino
๐ฎ๐นTorino, Italy
UO Ematologia, AOU Integrata di Verona
๐ฎ๐นVerona, Italy
Ematologia, Ospedale "Monsignor Raffaele Dimiccoli"
๐ฎ๐นBarletta, Italy
Divisione di Ematologia, A.O. Ospedali Riuniti Villa Sofia-Cervello
๐ฎ๐นPalermo, Italy
UO Ematologia, Istituto Clinico Humanitas
๐ฎ๐นRozzano, Italy