How MYC gene changes relate to the tumor immune environment in diffuse large B‑cell and high‑grade B‑cell lymphoma
Multicenter, Observational, Retrospective-prospective Study Exploring the Clinical Impact of MYC Aberrations and Their Relationship With Microenvironment in Diffuse Large B Cell Lymphoma and High-Grade B Cell Lymphoma
This project will see if MYC gene changes and the tumor's immune environment are linked in adults (18–79) who received curative treatment for diffuse large B‑cell or high‑grade B‑cell lymphoma.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 79 Years |
| Sex | All |
| Sponsor | Fondazione Italiana Linfomi - ETS Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 20 sites (Alessandria and 19 other locations) |
| Trial ID | NCT06588205 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults aged 18–79 with nodal or extranodal DLBCL or HGBCL diagnosed on/after 1 January 2019 who have a MYC translocation or MYC copy‑number gain (>3 copies in >30% of nuclei), received first‑line curative therapy, and have an adequate FFPE block and required IHC data.
Not a fit: Patients with primary CNS lymphoma, plasmablastic lymphoma, Burkitt lymphoma, primary mediastinal B‑cell lymphoma, those without MYC aberrations, or those lacking adequate tissue/sample or IHC information are unlikely to be eligible or benefit from this project's findings.
Why it matters
Potential benefit: If successful, the work could help identify patients with specific MYC and immune profiles who may benefit from tailored treatment intensity or immune‑directed approaches.
How similar studies have performed: Prior studies have shown MYC double‑ or triple‑hit status is associated with worse outcomes and that treatment intensification can reduce relapse risk but not clearly improve survival, while combining genetic and microenvironment analyses is an emerging but still maturing approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Alessandria and 19 other locations
- 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 — Padova, Italy (Not_yet_recruiting)
- I.R.C.C.S. Istituto Oncologico Veneto - U.O.C. Oncologia 1 — Padova, 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)
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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.