Diffuse Large B Cell Lymphoma (DLBCL)
Conditions
Brief summary
This is a retrospective analysis of the presence of chromosomal rearrangements involving MYC, BCL2 and BCL6 genes by FISH in a retrospective, single-center series of large B-cell lymphomas, in order to allow a better classifications of these cases according to the current WHO 2017 classification. If this evaluation will be confirmed as a reliable method to reclassify in different groups the evaluated tumors, it can be subsequently routinely apply to indicate the best treatment approaches in this high-risk setting of patients with a significant impact on patients' morbidity and mortality, and also on the health system and related costs.
Interventions
COMBINATION_PRODUCTTreatments: anthracycline-based combinations followed or not by involved-field radiotherapy
Anthracycline-based combinations followed or not by involved-field radiotherapy
Sponsors
Andrés José Maria Ferreri
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically-confirmed diagnosis of LBCL (i.e., DLBCL, HGBCL, unclassifiable B-cell lymphoma with features intermediate between DLBCL and BL), or aggressive B-cell lymphomas with blastoid morphology (excluding blastoid variant of mantle cell lymphoma and lymphoblastic lymphoma) * Histopathological diagnosis performed between 2000 and 2019. * HIV sero-negativity * Age ≥18 * Treatment with R-CHOP or other intensified polychemotherapy regimen * Availability of adequate histopathological samples at diagnosis for FISH analysis * Availability of clinical records and outcomes data
Exclusion criteria
• Histologic diagnosis other than DLBCL or unclassifiable B-cell lymphoma with features intermediate between DLBCL and BL
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | From the date of pathologic diagnosis until death from any cause or last follow-up, whichever occurs first, assessed up to 60 months | Overall survival (OS) is time from the date of pathologic diagnosis until death from any cause or last follow-up, whichever occurs first. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate | From the first day of treatment until the date of first documented response assessment, typically within 6 months of treatment initiation | the Overall Response Rate (ORR) measures the percentage of patients whose disease shows a reduction in size or is eliminated after a specific treatment. It includes patients who achieve either a Complete Response (CR), where all signs of the lymphoma disappear, or a Partial Response (PR), where there is a significant reduction in tumor burden but some signs of the disease remain |
| Duration of response (DOR; partial response [PR] + complete remission [CR]) | From the date of first documented response (CR or PR) until disease progression, relapse, death from any cause, or last follow-up, whichever occurs first, assessed up to 60 months | Time from the date of first documented response (complete or partial) until disease progression, relapse, death from any cause, or last follow-up, whichever occurs first. |
| Progression-free Survival (PFS) | From the first day of treatment until relapse, progression, death , or last follow-up, whichever occurs first, assessed up to 60 months | Progression-Free Survival (PFS) is the length of time during and after a disease treatment that a patient lives without the disease worsening or progressing |
| Relapse Pattern | From the date of first documented response (CR or PR) until disease relapse or last follow-up, whichever occurs first, assessed up to 60 months | Description of the type and location of disease relapse, including nodal vs extranodal and local vs systemic recurrence |
| Incidence of chromosomal rearrangements involving MYC gene and BCL2 gene (so called double hit lymphoma, representing 60% of HGBL) and/or BCL6 (also called triple hit lymphoma, representing 20% of HG in Large B-cell Lymphomas. | At the time of pathologic diagnosis (baseline) | Proportion of patients with documented genetic rearrangements of MYC, BCL2, or BCL6 detected at the time of pathologic diagnosis. |
| Relapse rates | From the date of first documented response (CR or PR) until disease relapse or last follow-up, whichever occurs first, assessed up to 60 months | Proportion of patients who experience disease relapse after achieving a complete or partial response. |
Countries
Italy
Outcome results
None listed