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This is a observational, retrospective and prospective study designed to assess the potential correlations between MYC alterations, lymphoma mutational landscape and functional immune contextures in Diffuse Large B-cell Lymphoma or High-Grade B-cell Lymphoma
Diffuse large B-cell lymphomas (DLBCL) and high-grade B-cell lymphomas (HGBCL) are a group of heterogeneous diseases representing more than a third of lymphomas in adults. 5-years overall survival of patients affected by DLBCL and HGBCL is around 70-60% and efficient prognostic markers are warranted to improve patients' survival by better tailored therapeutical approaches.
Genetic rearrangements of the MYC gene occur in 5-10% of DLBCL at diagnosis, and the presence of double translocations involving both MYC and BCL2 ("double-hit", DH), associated or not with BCL6 ("triple-hit", TH) translocation, is associated with unfavorable prognostic impact.
Intensification of treatment compared to standard chemotherapy (R-CHOP) appears to reduce the risk of recurrence in patients with DH or TH lymphomas, but a survival advantage has not been demonstrated.
Numerical changes in MYC (gain of copy number, GCN) may also affect the outcome of patients with DLBCL, but their prognostic relevance and the benefit of treatment intensification is still controversial.
Additionally, novel scientific evidence indicates a contribution of lymphoma micro-environment (LME) in disease genomic subtype and patient prognosis.
We aimed this study at investigating potential biological links between MYC aberrations, lymphoma mutational landscape and functional immune contextures in DLBCL and HGBCL.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients enrolled | Patient affected by DLBCL or HGBL with MYC alterations treated with standard R-chemotherapy regimens as first line treatment |
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| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the histopathological, genetic, clinical characteristics and outcome of patients with DLBCL or HGBCL with MYC rearrangements or GCN (alone or in association with BCL2 and BCL6) treated with curative intent therapy | Comparison of Progression Free Survival (PFS) according to genetic subgroups with or without intensified treatment | The endpoint will be evaluated from the beginning to the end of the study (up to 36 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Identify biological relationship between MYC aberration, gene mutations and patterns of immune microenvironment in B-cell lymphomas with DLBCL or high-grade morphology | % of patients with presence of MYC, BCL2 and/or BCL6 translocation evaluated by FISH | The endpoint will be evaluated from the beginning to the end of the study (up to 36 months) |
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Inclusion Criteria:
Exclusion Criteria:
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Patient affected by DLBCL or HGBL with MYC alterations treated with standard R-chemotherapy regimens as first line treatment
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Uffici Studi FIL | Contact | +390131033153 | startup@filinf.it | |
| Uffici Studi FIL | Contact | +390599769913 | gestionestudi@filinf.it |
| Name | Affiliation | Role |
|---|---|---|
| Luisa Lorenzi, MD | SC Anatomia Patologica - ASST Spedali Civili di Brescia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| A.O.U. SS. Antonio e Biagio e C. Arrigo - S.C.D.U. Ematologia | Recruiting | Alessandria | Italy |
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| Identify biological relationship between MYC aberration, gene mutations and patterns of immune microenvironment in B-cell lymphomas with DLBCL or high-grade morphology | % of patients with presence of MYC gain of copy (GCN: > 3 copies in more than 30% of the nuclei) evaluated by FISH | The endpoint will be evaluated from the beginning to the end of the study (up to 36 months) |
| Identify biological relationship between MYC aberration, gene mutations and patterns of immune microenvironment in B-cell lymphomas with DLBCL or high-grade morphology | % of patient with presence of MYC amplification evaluated by FISH | The endpoint will be evaluated from the beginning to the end of the study (up to 36 months) |
| Identify putative prognostic and predictive biomarkers related to the lymphoma microenvironment | Correlation between the microenvironment signature and patient Overall Survival (OS) | The endpoint will be evaluated from the beginning to the end of the study (up to 36 months) |
| Analyze the impact of the type of therapy, standard or intensified (with or without autotransplantation), on the outcome in the different subgroups of patients | Progression Free Survival comparison in the different subgroups of lymphomas and according to the type of treatment received | The endpoint will be evaluated from the beginning to the end of the study (up to 36 months) |
| Assess the risk of central nervous system (CNS) recurrence and the impact of prophylaxis performed with intrathecal chemotherapy vs methotrexate intravenous | Progression Free Survival comparison in the different subgroups of lymphomas and according to the type of treatment received | The endpoint will be evaluated from the beginning to the end of the study (up to 36 months) |
| A.O.U. Ospedali Riuniti delle Marche - Clinica di Ematologia | Recruiting | Ancona | Italy |
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| I.R.C.C.S. Istituto Tumori Giovanni Paolo II - U.O.C. Ematologia | Recruiting | Bari | Italy |
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| ASST Spedali Civili - S.C. Ematologia | Recruiting | Brescia | Italy |
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| I.R.C.C.S. Istituto di Candiolo - FPO | Recruiting | Candiolo | Italy |
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| I.R.C.C.S. Istituto Oncologico Veneto - U.O.C. Oncoematologia | Not yet recruiting | Castelfranco Veneto | Italy |
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| ARNAS Garibaldi - U.O.C. Ematologia | Recruiting | Catania | Italy |
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| A.S.T. Macerata - U.O.S.D Ematologia | Recruiting | Civitanova Marche | Italy |
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| Azienda Ospedaliera Universitaria Careggi - Unità funzionale di Ematologia | Recruiting | Florence | Italy |
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| ASST Grande Ospedale Metropolitano Niguarda - S.C. Ematologia | Recruiting | Milan | Italy |
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| Ospedale Maggiore Policlinico Fondazione IRCCS Ca' Granda - S.C. Ematologia | Recruiting | Milan | Italy |
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| A.O.U. di Padova - U.O.C. Ematologia | Not yet recruiting | Padova | Italy |
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| I.R.C.C.S. Istituto Oncologico Veneto - U.O.C. Oncologia 1 | Not yet recruiting | Padova | Italy |
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| AUSL Modena sede di Sassuolo - UOSD di Oncologia Area Sud | Recruiting | Sassuolo | Italy |
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| U.O.C. Ematologia - A.O.U. Senese | Not yet recruiting | Siena | Italy |
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| A.O.U. Città della Salute e della Scienza di Torino - S.C. Ematologia U | Not yet recruiting | Torino | Italy |
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| ULSS 2 Ospedale Ca' Foncello - U.O.C. Ematologia | Recruiting | Treviso | Italy |
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| A.O. Cardinale "G. Panico" - U.O.C Ematologia e Trapianto Midollo Osseo | Recruiting | Tricase | Italy |
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| A.S.U. Giuliano Isontina - S.C. Ematologia | Recruiting | Trieste | Italy |
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| A.O.U.I. di Verona - Ematologia | Not yet recruiting | Verona | Italy |
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| ID | Term |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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