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

Completed

• 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)

Study Timeline

• Study Start: 2019-10-02
• Study First Submitted: 2021-11-26
• Study First Submitted QC: 2021-12-16
• Study First Posted: 2021-12-17
• Primary Completion: 2022-12-05
• Status Verified: 2025-07
• Study Completion: 2025-07-11
• Last Update Submitted: 2025-07-11
• Last Update Posted: 2025-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 633

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.

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)

U.F. Oncoematologia, IOM (Istituto Oncologico del Mediterraneo); 🇮🇹 Viagrande, Catania, 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

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