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Clinical Trials in Italy / NCT06588205
Recruiting Observational

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 · tracked via the Priya Life Science Italy tracker
Sponsor
Fondazione Italiana Linfomi - ETS
Phase
Observational
Started
2025-05-05
Last updated
2025-12-29

Condition(s) studied

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

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

Sex
ALL
Min age
18 Years
Max age
79 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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 — The endpoint will be evaluated from the beginning to the end of the study (up to 36 months)
    Comparison of Progression Free Survival (PFS) according to genetic subgroups with or without intensified treatment

Trial sites (20)

FacilityCityRegionStatus
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

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Other trials for the same condition

Role of the Gut Microbiome in the Outcome of Diffuse Large B-Cell Lymphoma Patients Treated With CAR-T Cell Therapy Active, not recruiting
IKS03 in Patients With Advanced B Cell Non-Hodgkin Lymphomas Recruiting
Predictive Biomarkers Including miRNA-based Tumor Signatures in Diffuse Large B Cell Lymphoma (R/R DLBCL) (MIMOSA) Starting soon
Safety and Efficacy of KRT-232 in Combination With Acalabrutinib in Subjects With R/R DLBCL or R/R CLL Recruiting
A Study of Tulmimetostat DZR123 (CPI-0209) in Patients With Advanced Solid Tumors and Lymphomas Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06588205 on ClinicalTrials.gov ↗ ← All trials in Italy