Multicenter Retrospective Observational Study of Relapsed Diffuse Large B-Cell Lymphoma Presenting as Indolent Lymphoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Diffuse Large B Cell Lymphoma (DLBCL), Indolent B-Cell Lymphomas, Indolent B Cell Lymphoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Overall Survival (OS) [Time frame: Up to 2 years]
Secondary outcome measures (5)
- Progression-Free Survival (PFS) [Time frame: Up to 2 years]
- Response Rate [Time frame: Up to 2 years]
- Adverse Events [Time frame: Up to 2 years]
- Type of Therapy [Time frame: Up to 2 years]
- Cause of Death [Time frame: Up to 2 years]
Eligibility criteria
Inclusion criteria
- 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).
Exclusion criteria
\- None
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- Azienda USL IRCCS di Reggio Emilia — Reggio Emilia
Publications
- 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
Identifiers
NCT: NCT06822829 · 446/2023/OSS/IRCCSRE