Diffuse Large B Cell Lymphoma (DLBCL), Indolent B Cell Lymphoma, Indolent B-Cell Lymphomas
Conditions
Keywords
indolent relapse, diffuse large b cell lymphoma
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.
Interventions
None listed
Sponsors
Azienda USL Reggio Emilia - IRCCS
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | 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
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS) | 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. |
| Response Rate | 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). |
| Adverse Events | 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. |
| Type of Therapy | 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. |
| Cause of Death | Up to 2 years | Description of the causes of death, with particular focus on death due to disease progression versus other causes. |
Countries
Italy
Contacts
CONTACTAttilio Gennaro, Clinical Research Coordinator
PRINCIPAL_INVESTIGATORMaria Elena Nizzoli, MD
Azienda USL - IRCCS di Reggio Emilia
Outcome results
None listed