Clinical trial NCT06822829: Multicenter Retrospective Observational Study of Relapsed Diffuse Large B-Cell Lymphoma Presenting As Indolent Lymphoma
Official title: Multicenter Retrospective Observational Study of Relapsed Diffuse Large B-Cell Lymphoma Presenting As Indolent Lymphoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diffuse Large B Cell Lymphoma (DLBCL)
Indolent B-Cell Lymphomas
Indolent B Cell Lymphoma
Keywords: indolent relapse
diffuse large b cell lymphoma
Lead sponsor: Azienda USL Reggio Emilia - IRCCS
Sponsor class: OTHER_GOV
First posted: 2025-02-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.


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

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to 2 years
Secondary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: Up to 2 years
measure: Response Rate
timeFrame: Up to 2 years
measure: Adverse Events
timeFrame: Up to 2 years
measure: Type of Therapy
timeFrame: Up to 2 years
measure: Cause of Death
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Reggio Emilia
country: Italy
facility: Azienda USL IRCCS di Reggio Emilia
Study officials:
affiliation: Azienda USL - IRCCS di Reggio Emilia
name: Maria Elena Nizzoli, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.