Multicenter Retrospective Observational Study of Relapsed Diffuse Large B-Cell Lymphoma Presenting as Indolent Lymphoma

Обзор

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.

Первичные конечные точки

• Overall Survival (OS) [Срок оценки: Up to 2 years]

Вторичные конечные точки (5)

• Progression-Free Survival (PFS) [Срок оценки: Up to 2 years]
• Response Rate [Срок оценки: Up to 2 years]
• Adverse Events [Срок оценки: Up to 2 years]
• Type of Therapy [Срок оценки: Up to 2 years]
• Cause of Death [Срок оценки: Up to 2 years]

Критерии участия

Критерии включения

• Age 18 years or older at the time of diagnosis.
• Previous diagnosis of diffuse large B-cell lymphoma with/without a discordant component of indolent B-cell lymphoma, or previous diagnosis of diffuse large B-cell lymphoma transformed from indolent B-cell lymphoma.
• First-line treatment for diffuse large B-cell lymphoma.
• Histologically documented relapse of indolent B-cell lymphoma, diagnosed between 2010 and 2020.
• Availability of the histological report of the relapse.
• Availability of clinical and laboratory data related to both the initial diagnosis and relapse.
• Availability of follow-up data.
• Consent to participate in the study and signing of the specific informed consent form (for living and/or contactable patients).

Критерии исключения

\- None

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Италия · 1 центр

• Azienda USL IRCCS di Reggio Emilia — Reggio Emilia

Публикации

• 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. PMID 31350266
• 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. PMID 17043351

Идентификаторы

NCT: NCT06822829 · 446/2023/OSS/IRCCSRE

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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