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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adult subjects (> 18 years old) of any age and gender affected by large B-cell lymphoma. | 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)
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatments: anthracycline-based combinations followed or not by involved-field radiotherapy | Combination Product | Anthracycline-based combinations followed or not by involved-field radiotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Overall survival (OS) is time from the date of pathologic diagnosis until death from any cause or last follow-up, whichever occurs first. | From the date of pathologic diagnosis until death from any cause or last follow-up, whichever occurs first, assessed up to 60 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) | 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 | From the first day of treatment until relapse, progression, death , or last follow-up, whichever occurs first, assessed up to 60 months |
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Exclusion criteria
• Histologic diagnosis other than DLBCL or unclassifiable B-cell lymphoma with features intermediate between DLBCL and BL
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Adult subjects (> 18 years old) of any age and gender affected by large B-cell lymphomas
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS San Raffaele Hospital | Milan | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41832699 | Derived | Ferreri AJM, Erbella F, Angelillo P, Pecciarini L, Bongiovanni L, Nonis A, Cangi MG, Ponti MV, Saliani L, Fiore P, Bruno-Ventre M, Girlanda S, Marino F, Flospergher E, Cassanello G, Palumbo F, Calimeri T, Ponzoni M. Three-Hour Infusion of Methotrexate at 3 g/m2 With or Without Intrathecal Chemotherapy Significantly Reduces CNS Relapses and Improves Survival in Patients With Large B-Cell Lymphomas at Increased CNS Risk. Am J Hematol. 2026 Jun;101(6):1244-1254. doi: 10.1002/ajh.70283. Epub 2026 Mar 15. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 21, 2022 | Sep 5, 2025 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
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| Overall Response Rate |
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 |
| From the first day of treatment until the date of first documented response assessment, typically within 6 months of treatment initiation |
| Duration of response (DOR; partial response [PR] + complete remission [CR]) | 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. | 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 |
| Relapse rates | Proportion of patients who experience disease relapse after achieving a complete or partial response. | 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 |
| Relapse Pattern | Description of the type and location of disease relapse, including nodal vs extranodal and local vs systemic recurrence | 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 |
| 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. | Proportion of patients with documented genetic rearrangements of MYC, BCL2, or BCL6 detected at the time of pathologic diagnosis. | At the time of pathologic diagnosis (baseline) |
| D009369 |
| Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |