Real-World Study of DLBCL With Different Genetic Subtypes

Study Overview
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Brief Summary
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To collect and evaluate the data of real-world treatment regimen, efficacy, safety and survival information of DLBCL patients with different genetic suptypes

Detailed Description
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DLBCL is a highly common malignant tumor in Asia. The aim of the study is to observe and explore the clinical information on DLBCL patients with different genetic subtypes and to analyze the clinical characteristics and prognosis of different molecular subtypes of DLBCL. This study is a non-interventional real world, observational study and all registered data are collected from real clinical practice cases. The medical data includes patient demographic, tumor characteristics, laboratory examination, history of treatments, adverse reactions, efficacy results and possible prognostic factors. The results can guide future precision therapy for DLBCL.

Official Title
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A Real-World Study of Diffuse Large B-Cell Lymphoma (DLBCL) Patients With Different Genetic Subtypes

Conditions
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DLBCL - Diffuse Large B Cell Lymphoma, Lymphoma

Intervention / Treatment
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* Other: Other


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically-confirmed diffuse large B-cell lymphoma (DLBCL) Genetic subtype belonging to at least one of the seven subtypes by using next generation sequencing: MCD, BN2, N1, ST2, A53, EZB (MYC+, MYC-) and others Fully comprehension and signature of the informed consent form (ICF) for participation Exclusion Criteria: Those who refuse to use reliable methods of contraception during pregnancy, lactation or age-appropriate period Severe mental illness Patients deemed unsuitable for inclusion by the investigator

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All enrolled patients<br>All patient who signed the consent form for participation to the study | Other: Other<br>* real world treatment and survival of DLBCL patients in China<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | Progression-free survival (PFS) is defined as the time from the date of first administration to the date of first disease progression or death from any cause, whichever occurs first. | Baseline up to data cut-off (Up to approximately 9 years) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ORR | Objective Remission Rate (ORR) is defined as the proportion of patients with complete remission (CR) and partial remission (PR) | End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days] | 
| CRR | Complete Remission Rate (CRR) is defined as the proportion of patients with CR | End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days] | 
| OS | Overall survival (OS) refers to the time from receiving the first dose to death from any cause | Baseline up to data cut-off (Up to approximately 9 years) | 
| DOR | Duration Of Remission (DOR) refers to the time from the first CR or PR to the time of the first PD or death from any cause | Baseline up to data cut-off (Up to approximately 9 years) | 
| TTR | Time to remission (TTR) refers to the time from recruitment to the time first CR or PR | Approximately up to 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lymphoma, DLBCL, Genetic Subtype, real world analysis