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

Primary Mediastinal Large B-cell Lymphoma (PMBCL) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05162170
• Other study ID #: FIL_PMBCL
• Status: Active, not recruiting
• Start date: October 2, 2019
• Est. completion date: June 21, 2024

Study information

• Verified date: June 2024
• Source: Fondazione Italiana Linfomi - ETS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 633
• Est. completion date: June 21, 2024
• Est. primary completion date: December 5, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, B-Cell
• Primary Mediastinal Large B-cell Lymphoma (PMBCL)

Locations

Country	Name	City	State
Italy	SC Ematologia, A.O. SS. Antonio e Biagio e Cesare Arrigo	Alessandria
Italy	Clinica di Ematologia, AOU Ospedali Riuniti	Ancona
Italy	Azienda Ospedaliera S.Giuseppe Moscati - S.C. Ematologia e Trapianto emopoietico	Avellino
Italy	Divisione di Oncologia e dei Tumori immuno-correlati, IRCCS Centro di Riferimento Oncologico di Aviano	Aviano
Italy	U.O. Ematologia con Trapianto, AOU Policlinico Consorziale	Bari
Italy	U.O.C. Ematologia - IRCCS Istituto Tumori Giovanni Paolo II	Bari
Italy	Ematologia, Ospedale "Monsignor Raffaele Dimiccoli"	Barletta
Italy	Istituto di Ematologia "Seragnoli", Policlinico S.Orsola-Malpighi	Bologna
Italy	Ematologia, ASST Spedali Civili di Brescia	Brescia
Italy	U.O. Ematologia e Trapianti di Midollo, Ospedale Antonio Perrino	Brindisi
Italy	SC Ematologia e CTMO, Ospedale Businco	Cagliari
Italy	Arnas Nuovo Ospedale Garibaldi Nesima	Catania
Italy	Ematologia, Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele Presidio Ospedale Ferrarotto	Catania
Italy	UOC Ematologia, Azienda Ospedaliera di Cosenza	Cosenza
Italy	Unit? funzionale di Ematologia, Azienda Ospedaliera Universitaria Careggi	Firenze
Italy	Ematologia, Ospedale Vito Fazzi	Lecce
Italy	Ematologia, Ospedale Madonna delle Grazie	Matera
Italy	SC Ematologia, Azienda Ospedali Riuniti Papardo-Piemonte	Messina
Italy	Divisione Ematoncologia, IEO Istitito Europeo di Oncologia	Milano
Italy	Ematologia, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano	Milano
Italy	SC Ematologia, ASST Grande Ospedale Metropolitano Niguarda	Milano
Italy	UOC Ematologia Oncologica, Istituto Nazionale Tumori - IRCCS Fondazione G. Pascale	Napoli
Italy	Istituto Oncologico Veneto I.R.C.C.S.	Padova
Italy	Divisione di Ematologia, A.O. Ospedali Riuniti Villa Sofia-Cervello	Palermo
Italy	Ematologia, AOU Policlinico Giaccone	Palermo
Italy	Oncoematologia e TMO Dip. Oncologia, Casa di Cura La Maddalena	Palermo
Italy	Azienda Ospedaliera Universitaria Pisana - U.O. Ematologia	Pisa
Italy	Ematologia, Grande Ospedale Metropolitano Bianchi Melacrino Morelli	Reggio Calabria
Italy	Ematologia, Azienda Unit? Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova	Reggio Emilia
Italy	Ematologia, Ospedale S. Camillo	Roma
Italy	Ematologia, Universit? Cattolica S. Cuore	Roma
Italy	Istituto Ematologia -Dipartimento di Medicina Traslazionale e di Precisione,Policlinico Umberto I - Universit? "La Sapienza"	Roma
Italy	UO Ematologia, Istituto Clinico Humanitas	Rozzano
Italy	UO Ematologia, Casa Sollievo della Sofferenza	San Giovanni Rotondo
Italy	SC Ematologia, Ospedale "S.G. Moscati"	Taranto
Italy	Azienda Ospedaliera Santa Maria - S.C. Oncoematologia	Terni
Italy	Ematologia Universitaria, A.O.U. Citta della Salute e della Scienza di Torino	Torino
Italy	SC Ematologia, A.O.U. Citta della Salute e della Scienza di Torino	Torino
Italy	UO Ematologia, AOU Integrata di Verona	Verona
Italy	U.F. Oncoematologia, IOM (Istituto Oncologico del Mediterraneo)	Viagrande	Catania

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Italiana Linfomi - ETS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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
Primary	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)
Primary	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	Acute toxicity	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)
Secondary	Long-term toxicity	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)