Status:

RECRUITING

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

Lead Sponsor:

Fondazione Italiana Linfomi - ETS

Conditions:

Diffuse Large B Cell Lymphoma

High-grade B-cell Lymphoma

Eligibility:

All Genders

18-79 years

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 D...

Detailed Description

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 ...

Eligibility Criteria

Inclusion

  • 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

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

Key Trial Info

Start Date :

May 5 2025

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

December 1 2027

Estimated Enrollment :

200 Patients enrolled

Trial Details

Trial ID

NCT06588205

Start Date

May 5 2025

End Date

December 1 2027

Last Update

December 29 2025

Active Locations (20)

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Page 1 of 5 (20 locations)

1

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

Alessandria, Italy

2

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

Ancona, Italy

3

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

Bari, Italy

4

ASST Spedali Civili - S.C. Ematologia

Brescia, Italy