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

Last updated: September 4, 2025
Sponsor: Fondazione Italiana Linfomi - ETS
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lymphoma, B-cell

Lymphoma

Treatment

N/A

Clinical Study ID

NCT06588205
FIL_MIMYC
  • Ages 18-79
  • All Genders

Study Summary

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

Inclusion

Inclusion Criteria:

  • Diagnosis of nodal and extranodal Diffuse Large B Cell Lymphoma, High Grade B CellLymphomas (including low-grade transformed lymphomas; double and triple hit; 11qaberration; 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 "Burkittlike" chemotherapies) as first-line therapy

  • Histological material of adequate size and quality to perform histological reviewwith any additional investigations (immunohistochemistry, FISH and other molecularanalysis). A FFPE block must be provided for patient enrollment.

  • Age between 18 and 79 years

Exclusion

Exclusion Criteria:

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

  • Have received palliative treatment

Study Design

Total Participants: 200
Study Start date:
May 05, 2025
Estimated Completion Date:
December 31, 2027

Study Description

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.

Connect with a study center

  • A.O.U. SS. Antonio e Biagio e C. Arrigo - S.C.D.U. Ematologia

    Alessandria,
    Italy

    Site Not Available

  • A.O.U. SS. Antonio e Biagio e C. Arrigo - S.C.D.U. Ematologia

    Alessandria 3183299,
    Italy

    Active - Recruiting

  • A.O.U. Ospedali Riuniti delle Marche - Clinica di Ematologia

    Ancona,
    Italy

    Site Not Available

  • A.O.U. Ospedali Riuniti delle Marche - Clinica di Ematologia

    Ancona 3183089,
    Italy

    Active - Recruiting

  • I.R.C.C.S. Istituto Tumori Giovanni Paolo II - U.O.C. Ematologia

    Bari,
    Italy

    Site Not Available

  • I.R.C.C.S. Istituto Tumori Giovanni Paolo II - U.O.C. Ematologia

    Bari 3182351,
    Italy

    Active - Recruiting

  • ASST Spedali Civili - S.C. Ematologia

    Brescia,
    Italy

    Site Not Available

  • ASST Spedali Civili - S.C. Ematologia

    Brescia 3181554,
    Italy

    Active - Recruiting

  • I.R.C.C.S. Istituto di Candiolo - FPO

    Candiolo,
    Italy

    Site Not Available

  • I.R.C.C.S. Istituto di Candiolo - FPO

    Candiolo 3180861,
    Italy

    Active - Recruiting

  • I.R.C.C.S. Istituto Oncologico Veneto - U.O.C. Oncoematologia

    Castelfranco Veneto,
    Italy

    Site Not Available

  • I.R.C.C.S. Istituto Oncologico Veneto - U.O.C. Oncoematologia

    Castelfranco Veneto 3179684,
    Italy

    Site Not Available

  • ARNAS Garibaldi - U.O.C. Ematologia

    Catania,
    Italy

    Site Not Available

  • ARNAS Garibaldi - U.O.C. Ematologia

    Catania 2525068,
    Italy

    Active - Recruiting

  • A.S.T. Macerata - U.O.S.D Ematologia

    Civitanova Marche,
    Italy

    Site Not Available

  • A.S.T. Macerata - U.O.S.D Ematologia

    Civitanova Marche 3170102,
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Careggi - Unità funzionale di Ematologia

    Firenze,
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Careggi - Unità funzionale di Ematologia

    Florence 3176959,
    Italy

    Site Not Available

  • ASST Grande Ospedale Metropolitano Niguarda - S.C. Ematologia

    Milan 6951411,
    Italy

    Site Not Available

  • Ospedale Maggiore Policlinico Fondazione IRCCS Ca' Granda - S.C. Ematologia

    Milan 6951411,
    Italy

    Site Not Available

  • ASST Grande Ospedale Metropolitano Niguarda - S.C. Ematologia

    Milano,
    Italy

    Site Not Available

  • Ospedale Maggiore Policlinico Fondazione IRCCS Ca' Granda - S.C. Ematologia

    Milano,
    Italy

    Site Not Available

  • A.O.U. Federico II - U.O.C. Ematologia

    Napoli,
    Italy

    Site Not Available

  • A.O.U. di Padova - U.O.C. Ematologia

    Padova,
    Italy

    Site Not Available

  • I.R.C.C.S. Istituto Oncologico Veneto - U.O.C. Oncologia 1

    Padova,
    Italy

    Site Not Available

  • A.O.U. di Padova - U.O.C. Ematologia

    Padua 3171728,
    Italy

    Site Not Available

  • I.R.C.C.S. Istituto Oncologico Veneto - U.O.C. Oncologia 1

    Padua 3171728,
    Italy

    Site Not Available

  • AUSL di Modena - U.O.S.D. Oncologia

    Sassuolo,
    Italy

    Site Not Available

  • AUSL Modena sede di Sassuolo - UOSD di Oncologia Area Sud

    Sassuolo 3167053,
    Italy

    Site Not Available

  • U.O.C. Ematologia - A.O.U. Senese

    Siena,
    Italy

    Site Not Available

  • U.O.C. Ematologia - A.O.U. Senese

    Siena 3166548,
    Italy

    Site Not Available

  • A.O.U. Città della Salute e della Scienza di Torino - S.C. Ematologia U

    Torino,
    Italy

    Site Not Available

  • A.O.U. Città della Salute e della Scienza di Torino - S.C. Ematologia U

    Torino 8980539,
    Italy

    Site Not Available

  • ULSS 2 Ospedale Ca' Foncello - U.O.C. Ematologia

    Treviso,
    Italy

    Site Not Available

  • ULSS 2 Ospedale Ca' Foncello - U.O.C. Ematologia

    Treviso 3165201,
    Italy

    Active - Recruiting

  • A.O. Cardinale "G. Panico" - U.O.C Ematologia e Trapianto Midollo Osseo

    Tricase,
    Italy

    Site Not Available

  • A.O. Cardinale "G. Panico" - U.O.C Ematologia e Trapianto Midollo Osseo

    Tricase 2522857,
    Italy

    Site Not Available

  • A.S.U. Giuliano Isontina - S.C. Ematologia

    Trieste,
    Italy

    Site Not Available

  • A.S.U. Giuliano Isontina - S.C. Ematologia

    Trieste 3165185,
    Italy

    Active - Recruiting

  • A.O.U.I. di Verona - Ematologia

    Verona,
    Italy

    Site Not Available

  • A.O.U.I. di Verona - Ematologia

    Verona 3164527,
    Italy

    Site Not Available

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