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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAzienda USL Reggio Emilia - IRCCS

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial 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.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

50 Participants
are grouped into 1 trial group
Group A: Patients diagnosed with diffuse large B-cell lymphoma

Trial outcomes

Primary outcomes

1

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.

Time frame
Up to 2 years

Secondary outcomes

1

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.

Time frame
Up to 2 years
2

Response Rate

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).

Time frame
Up to 2 years
3

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.

Time frame
Up to 2 years
4

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.

Time frame
Up to 2 years

Other outcomes

Sponsors and contacts

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