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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-05-05

Study Completion Date

2027-12-31

Brief Summary

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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

Detailed Description

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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.

Conditions

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

Keywords

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Patients enrolled

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

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Luisa Lorenzi, MD

Role: PRINCIPAL_INVESTIGATOR

SC Anatomia Patologica - ASST Spedali Civili di Brescia

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Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

Patients enrolled

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Fondazione Italiana Linfomi - ETS

Responsible Party

Principal Investigators

Luisa Lorenzi, MD

Locations

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

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

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

ASST Spedali Civili - S.C. Ematologia

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

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

ARNAS Garibaldi - U.O.C. Ematologia

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

Azienda Ospedaliera Universitaria Careggi - Unità funzionale di Ematologia

ASST Grande Ospedale Metropolitano Niguarda - S.C. Ematologia

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

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

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

AUSL Modena sede di Sassuolo - UOSD di Oncologia Area Sud

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

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

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

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

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

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

Countries

Central Contacts

Uffici Studi FIL

Uffici Studi FIL

Facility Contacts

Manuela Zanni, MD

Guido Gini, MD

Sabino Ciavarella, MD

Chiara Pagani, MD

Valentina Sangiorgio, MD

Mariella Lo Schirico, MD

Ugo Consoli, MD

Caterina Bocci, MD

Benedetta Sordi, MD

Emanuele Ravano, MD

Francesca Gaia Rossi, MD

Greta Scapinello, MD

Dario Marino, MD

Sara Bigliardi, MD

Alberto Fabbri, MD

Federica Cavallo, MD

Piero Maria Stefani, MD

Anna Mele, MD

Elisa Lucchini, MD

Francesca Maria Quaglia, MD

Other Identifiers

FIL_MIMYC