Exploring the Clinical Impact of MYC Aberrations and Their Relationship With Microenvironment in Diffuse Large B Cell Lymphoma and High-Grade B Cell Lymphoma

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-79
SponsorFondazione Italiana Linfomi - ETS

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of nodal and extranodal Diffuse Large B Cell Lymphoma, High Grade B Cell Lymphomas (including low-grade transformed lymphomas; double and triple hit; 11q aberration; not otherwise specified) after 1st January 2019

Presence of one MYC translocation or gain of copies (GCN: > 3 copies in more than 30% of the nuclei) or amplification evaluated by FISH

Availability of immunohistochemical analysis of CD10, Bcl6, MUM1, Bcl2, Myc, Ki67

Have received curative treatment (e.g. R-CHOP, R DA EPOCH, intensified "Burkitt like" chemotherapies) as first-line therapy

Disqualifiers

Primary lymphomas of the central nervous system, plasmablastic lymphoma, Burkitt's lymphoma, primary mediastinal B lymphoma

Have received palliative treatment

Trial population

Patient affected by DLBCL or HGBL with MYC alterations treated with standard R-chemotherapy regimens as first line treatment

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

200 Participants
are grouped into 1 trial group
Group A: Patients enrolled

Trial outcomes

Primary outcomes

1

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)

Secondary outcomes

1

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)
2

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)
3

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)
4

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)

Other outcomes

Sponsors and contacts

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