How MYC gene changes relate to the tumor immune environment in diffuse large B‑cell and high‑grade B‑cell lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study combines retrospective and prospective cases to correlate MYC alterations (translocations, copy‑number gain, amplification) with the tumor mutational landscape and functional immune contextures in DLBCL and HGBCL. Eligible patients have available FFPE tissue and baseline immunohistochemistry (CD10, Bcl6, MUM1, Bcl2, Myc, Ki67) and underwent first‑line curative therapy. Molecular analyses include FISH for MYC/BCL2/BCL6 rearrangements and additional genomic profiling, with comparison to immune cell signatures and clinicopathologic outcomes. The goal is to define biological links that could refine prognostic groups and inform treatment intensity decisions.

Why it matters

Who can join: the full rules

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

Where it's running

• 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
• ARNAS Garibaldi - U.O.C. Ematologia
  Catania, Italy Recruiting

Study contacts

• Principal investigator: Luisa Lorenzi, MD — SC Anatomia Patologica - ASST Spedali Civili di Brescia
• Study coordinator: Uffici Studi FIL
• Email: startup@filinf.it
• Phone: +390131033153

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.