A Retrospective Study on Extranodal DLBCL

Completed

• Conditions: Diffuse Large B Cell Lymphoma; Lymphoma; Extranodal Lymphoma

• Registration Number: NCT06549361
• Lead Sponsor: Ruijin Hospital

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.

Study Timeline

• Study Start: 2022-05-01
• Primary Completion: 2023-07-01
• Study Completion: 2023-09-01
• Status Verified: 2024-08
• Study First Submitted: 2024-08-08
• Study First Submitted QC: 2024-08-08
• Last Update Submitted: 2024-08-08
• Study First Posted: 2024-08-12
• Last Update Posted: 2024-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5023

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Clinical characteristics form	Baseline 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.

Trial Locations

Locations (1)

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China