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

NCT06588205 | Recruiting

• 1 other identifier: FIL_MIMYC
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 20

Brief 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

Conditions

High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements; High-grade B-cell Lymphoma; Diffuse Large B Cell Lymphoma

Keywords

Diffuse Large B Cell Lymphoma; High-grade B-cell Lymphoma; MYC; BCL2; BCL6; Double Hit; Triple Hit; lymphoma micro-environment

Outcome Measures

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

  The endpoint will be evaluated from the beginning to the end of the study (up to 36 months)

Secondary Outcomes (6)

• Identify biological relationship between MYC aberration, gene mutations and patterns of immune microenvironment in B-cell lymphomas with DLBCL or high-grade morphology

  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

  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

  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

  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

  The endpoint will be evaluated from the beginning to the end of the study (up to 36 months)

Study Arms (1)

Patients enrolled

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

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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
• Histological material of adequate size and quality to perform histological review with any additional investigations (immunohistochemistry, FISH and other molecular analysis). A FFPE block must be provided for patient enrollment.
• Age between 18 and 79 years

You may not qualify if:

• Primary lymphomas of the central nervous system, plasmablastic lymphoma, Burkitt's lymphoma, primary mediastinal B lymphoma
• Have received palliative treatment

Sponsors & Collaborators

• Fondazione Italiana Linfomi - ETS: lead

Study Sites (20)

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

Alessandria, Italy

RECRUITING

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

Ancona, Italy

RECRUITING

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

Bari, Italy

RECRUITING

ASST Spedali Civili - S.C. Ematologia

Brescia, Italy

RECRUITING

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

Candiolo, Italy

RECRUITING

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

Castelfranco Veneto, Italy

NOT YET RECRUITING

ARNAS Garibaldi - U.O.C. Ematologia

Catania, Italy

RECRUITING

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

Civitanova Marche, Italy

RECRUITING

Azienda Ospedaliera Universitaria Careggi - Unità funzionale di Ematologia

Florence, Italy

RECRUITING

ASST Grande Ospedale Metropolitano Niguarda - S.C. Ematologia

Milan, Italy

RECRUITING

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

Milan, Italy

RECRUITING

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

Padua, Italy

NOT YET RECRUITING

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

Padua, Italy

NOT YET RECRUITING

AUSL Modena sede di Sassuolo - UOSD di Oncologia Area Sud

Sassuolo, Italy

RECRUITING

U.O.C. Ematologia - A.O.U. Senese

Siena, Italy

NOT YET RECRUITING

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

Torino, Italy

NOT YET RECRUITING

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

Treviso, Italy

RECRUITING

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

Tricase, Italy

RECRUITING

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

Trieste, Italy

RECRUITING

A.O.U.I. di Verona - Ematologia

Verona, Italy

NOT YET RECRUITING

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Luisa Lorenzi, MD

  SC Anatomia Patologica - ASST Spedali Civili di Brescia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Uffici Studi FIL

CONTACT

+390131033153; startup@filinf.it

Uffici Studi FIL

CONTACT

+390599769913; gestionestudi@filinf.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2024
• First Posted: September 19, 2024
• Study Start: May 5, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 29, 2025

Record last verified: 2025-12

Locations

IT (20)