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.
Study Type
OBSERVATIONAL
Enrollment
200
A.O.U. SS. Antonio e Biagio e C. Arrigo - S.C.D.U. Ematologia
Alessandria, Italy
RECRUITINGA.O.U. Ospedali Riuniti delle Marche - Clinica di Ematologia
Ancona, Italy
RECRUITINGI.R.C.C.S. Istituto Tumori Giovanni Paolo II - U.O.C. Ematologia
Bari, Italy
RECRUITINGASST Spedali Civili - S.C. Ematologia
Brescia, Italy
RECRUITINGI.R.C.C.S. Istituto di Candiolo - FPO
Candiolo, Italy
RECRUITINGI.R.C.C.S. Istituto Oncologico Veneto - U.O.C. Oncoematologia
Castelfranco Veneto, Italy
NOT_YET_RECRUITINGARNAS Garibaldi - U.O.C. Ematologia
Catania, Italy
RECRUITINGA.S.T. Macerata - U.O.S.D Ematologia
Civitanova Marche, Italy
RECRUITINGAzienda Ospedaliera Universitaria Careggi - Unità funzionale di Ematologia
Florence, Italy
RECRUITINGASST Grande Ospedale Metropolitano Niguarda - S.C. Ematologia
Milan, Italy
RECRUITING...and 10 more locations
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
Time frame: 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 patients with presence of MYC, BCL2 and/or BCL6 translocation evaluated by FISH
Time frame: 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 patients with presence of MYC gain of copy (GCN: \> 3 copies in more than 30% of the nuclei) evaluated by FISH
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: The endpoint will be evaluated from the beginning to the end of the study (up to 36 months)
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