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NCT Number: NCT06822829

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

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.

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Key information

Conditions

Diffuse Large B Cell Lymphoma (DLBCL) Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Indolent B Cell Lymphoma Indolent B-cell Lymphomas Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Azienda USL IRCCS di Reggio Emilia

Reggio Emilia, Italy

Location status: Recruiting

Location contact

Attilio Gennaro, Clinical Research Coordinator

CONTACT

[email protected]

Maria Elena Nizzoli, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Overall Survival (OS)

    Time frame: Up to 2 years

    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.

Secondary outcomes

  1. Progression-Free Survival (PFS)

    Time frame: Up to 2 years

    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.

  2. Response Rate

    Time frame: Up to 2 years

    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).

  3. Adverse Events

    Time frame: Up to 2 years

    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.

  4. Type of Therapy

    Time frame: Up to 2 years

    Description of the therapeutic pathway adopted for first-line treatment of diffuse large B-cell lymphoma and second-line treatment for indolent lymphoma relapse.

  5. Cause of Death

    Time frame: Up to 2 years

    Description of the causes of death, with particular focus on death due to disease progression versus other causes.

Study contacts

Contact information is provided by the study sponsor or research team.

Attilio Gennaro, Clinical Research Coordinator

CONTACT

[email protected]

+39 0522 295175

Sponsors and collaborators

Lead sponsor

Azienda USL Reggio Emilia - IRCCS

Other Gov

Registry information

Acronym: REVERSE_2021

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Feb 12, 2025
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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