Primary Mediastinal Large B-cell Lymphoma (PMBCL)
Conditions
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)
Interventions
None listed
Sponsors
Fondazione Italiana Linfomi - ETS
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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 |
| 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 |
| 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 |
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Italy
Contacts
PRINCIPAL_INVESTIGATORUgo Consoli
U.O.C Ematologia, ARNAS Garibaldi; P.O. Garibaldi - Nesima, Catania.
Outcome results
None listed