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

NCT ID: NCT06822829

Last Updated: 2025-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-19

Study Completion Date

2026-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Diffuse Large B Cell Lymphoma (DLBCL) Indolent B-Cell Lymphomas Indolent B Cell Lymphoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda USL Reggio Emilia - IRCCS

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maria Elena Nizzoli, MD

Role: PRINCIPAL_INVESTIGATOR

Azienda USL - IRCCS di Reggio Emilia

Locations

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Azienda USL IRCCS di Reggio Emilia

Reggio Emilia, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Attilio Gennaro, Clinical Research Coordinator

Role: CONTACT

+39 0522 295175

Facility Contacts

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Attilio Gennaro, Clinical Research Coordinator

Role: primary

Maria Elena Nizzoli, MD

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 31350266 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17043351 (View on PubMed)

Other Identifiers

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446/2023/OSS/IRCCSRE

Identifier Type: -

Identifier Source: org_study_id

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