Clinical trial · 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
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
NCT06588205CI-TRIAL-00099787FIL_MIMYCrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diffuse Large B Cell Lymphoma | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.80 |
| High-grade B-cell Lymphoma | High Grade B-Cell Lymphoma | CURATED_BROADER | 0.80 |
| High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements | High Grade B-Cell Lymphoma with MYC and BCL2 or BCL6 Rearrangements | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Patients enrolled
- description
- Patient affected by DLBCL or HGBL with MYC alterations treated with standard R-chemotherapy regimens as first line treatment
Primary outcomes (1)
- measure
- 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
- timeFrame
- The endpoint will be evaluated from the beginning to the end of the study (up to 36 months)
- description
- Comparison of Progression Free Survival (PFS) according to genetic subgroups with or without intensified treatment
Secondary outcomes (6)
- measure
- Identify biological relationship between MYC aberration, gene mutations and patterns of immune microenvironment in B-cell lymphomas with DLBCL or high-grade morphology
- timeFrame
- The endpoint will be evaluated from the beginning to the end of the study (up to 36 months)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 79 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.