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Most relapses of diffuse large B-cell lymphoma (DLBCL) occur as high-grade lymphoma within the first two years after diagnosis. Relapses as indolent lymphoma are rare events, and the true incidence of this phenomenon is unknown, since literature data are scarce/ and usually restricted to case reports. Analogously, reported treatment strategies are rather heterogeneous, since no standard of care is established and advanced age together with previous anthracycline exposure may narrow the therapeutic choice.
The goal of this observational study is to assess epidemiological, clinical characteristics and survival of diffuse large b-cell lymphoma (DLBCL) relapsing as indolent lymphoma.
More precisely, the study aims at identifying diagnostic and imaging features associated with relapse as indolent lymphoma and at evaluating disease response to selected therapies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients diagnosed with diffuse large B-cell lymphoma | Retrospective cohort of patients diagnosed with diffuse large B-cell lymphoma (DLBCL) who relapsed as indolent B-cell lymphoma between 2010 and 2020 |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS is calculated from the date of initiation of treatment for indolent lymphoma relapse to death from any cause or the last follow-up for censored cases. | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | PFS is measured from the date of initiation of treatment for indolent lymphoma relapse until disease progression or death, or the last follow-up for censored cases. | Up to 2 years |
| Response Rate |
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Inclusion Criteria:
Exclusion Criteria:
- None
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The study will be proposed to patients diagnosed with diffuse large B-cell lymphoma (DLBCL) who have relapsed as indolent B-cell lymphoma, with a histologically confirmed diagnosis of relapse and availability of the histological report. Patients who are still alive will be contacted and informed by the specialist about the study's objectives and will be required to sign a specific informed consent form. For patients lost to follow-up or deceased, a waiver of informed consent has been obtained from the Ethics Committee in accordance with applicable regulations.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Attilio Gennaro, Clinical Research Coordinator | Contact | +39 0522 295175 | attilio.gennaro@ausl.re.it |
| Name | Affiliation | Role |
|---|---|---|
| Maria Elena Nizzoli, MD | Azienda USL - IRCCS di Reggio Emilia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda USL IRCCS di Reggio Emilia | Recruiting | Reggio Emilia | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31350266 | Background | Wang Y, Link BK, Witzig TE, Maurer MJ, Allmer C, King RL, Feldman AL, Habermann TM, Ansell SM, Slager SL, Cerhan JR, Nowakowski GS. Impact of concurrent indolent lymphoma on the clinical outcome of newly diagnosed diffuse large B-cell lymphoma. Blood. 2019 Oct 17;134(16):1289-1297. doi: 10.1182/blood.2019000858. | |
| 17043351 | Background |
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Response to treatment for indolent B-cell lymphoma relapse will be assessed in terms of complete response, partial response, stable disease, and progression, according to the Lugano Classification criteria (Cheson B et al, JCO 2014).
| Up to 2 years |
| Adverse Events | Long-term adverse events occurring during follow-up (after treatment for indolent lymphoma relapse) will be categorized and graded according to the Common Toxicity Criteria for Adverse Events, referencing the most recent version available. | Up to 2 years |
| Type of Therapy | Description of the therapeutic pathway adopted for first-line treatment of diffuse large B-cell lymphoma and second-line treatment for indolent lymphoma relapse. | Up to 2 years |
| Cause of Death | Description of the causes of death, with particular focus on death due to disease progression versus other causes. | Up to 2 years |
| Ghesquieres H, Berger F, Felman P, Callet-Bauchu E, Bryon PA, Traverse-Glehen A, Thieblemont C, Baseggio L, Michallet AS, Coiffier B, Salles G. Clinicopathologic characteristics and outcome of diffuse large B-cell lymphomas presenting with an associated low-grade component at diagnosis. J Clin Oncol. 2006 Nov 20;24(33):5234-41. doi: 10.1200/JCO.2006.07.5671. Epub 2006 Oct 16. |
| 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 |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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