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A Retrospective Study on Extranodal DLBCL

The Retrospective Clinical Study of Extranodal Diffuse Large B-Cell Lymphoma

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06549361
Enrollment
5023
Registered
2024-08-12
Start date
2022-05-01
Completion date
2023-09-01
Last updated
2024-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diffuse Large B Cell Lymphoma, Extranodal Lymphoma, Lymphoma

Keywords

Lymphoma, Extranodal

Brief summary

The aim of this study is to prospectively collect clinical information of patients with extranodal DLBCL, assess the effectiveness of treatment for extranodal DLBCL in the real world, and explore the optimal treatment strategies in real-world populations.

Detailed description

DLBCL is a highly common aggressive non-Hodgkin's lymphoma. For specific extranodal sites of DLBCL, traditional chemotherapy protocols often cannot provide satisfactory results for patients. The aim of this study is to prospectively collect clinical information of patients with extranodal DLBCL, including the distribution of involved sites (such as central nervous system, testes, skin, breast, gastrointestinal tract, etc.), prognosis of diffuse large B-cell lymphoma with involvement of different extranodal sites, genetic mutation characteristics, correlation with molecular subtypes, impact of different treatment regimens on efficacy, assess the effectiveness of treatment for extranodal DLBCL in the real world, and explore the optimal treatment strategies in real-world populations.

Interventions

No interventions need to be specified for this study

Sponsors

Ruijin Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 1\. ≥ 18 years (including 18 years). * 2\. Pathologically diagnosed with diffuse large B-cell lymphoma according to the 2016 WHO classification, including non-specific types and various special subtypes. * 3\. Newly diagnosed DLBCL with involvement of extranodal organs. * 4\. Patients who have received clinical treatment for lymphoma. * 5.Patients with measurable lesions, including at least one effective efficacy assessment.

Exclusion criteria

* 1\. Patients receiving supportive care only. * 2\. Patients who cannot obtain effective efficacy assessment data.

Design outcomes

Primary

MeasureTime frameDescription
Overall Survival (OS)Time Frame: Baseline up to data cut-off (up to approximately 1 year)Overall Survival (OS) will be defined from the start date of therapy to the date of death from any cause.
Progression Free Survival (PFS)Time Frame: Baseline up to data cut-off (up to approximately 1 year)Progression-Free Survival (PFS) will be defined from the date of starting therapy and the date of disease progression, relapse or death from any cause.

Secondary

MeasureTime frameDescription
Clinical characteristics formBaseline up to data cut-off (up to approximately 1 year)Clinical characteristics from data filled into registry forms by physicians and data managers, including but not limited to values of lactate dehydrogenase, clinical stage, performance status, age ≥ 60 years and number and location of extranodal localizations.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026