Translational Study of Molecular Classification of Relapsed/Refractory Diffuse Large B-cell Lymphoma

Study Overview
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Brief Summary
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The purpose of the study is to investigate the proportion of the cell-of-origin (COO) subtypes in relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) treated with BTK inhibitor or lenalidomide and its biosimilars.

Detailed Description
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This is a multi-center, observational, retrospective study that examines approximately 200 R/R DLBCL patients treated with BTK inhibitors or lenalidomide and its biosimilars. For patients meet the inclusion criteria, gene expression analysis is performed on formalin fixed paraffin-embedded tissue by using Canhelp-COO Assay, and determine the COO subtype for each specimen. The proportion of COO subtypes in R/R DLBCL and the correlation between COO subtypes and clinicopathological information are further analyzed.

Official Title
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Translational Study of Molecular Classification of Relapsed/Refractory Diffuse Large B-cell Lymphoma

Conditions
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Lymphoma, Large B-Cell, Diffuse, Gene Expression Profiling

Intervention / Treatment
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* Diagnostic Test: Gene expression profile


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically-confirmed diagnosis of DLBCL, including transformed large B-cell lymphoma from previous indolent lymphoma. Meet the definition of relapsed/refractory DLBCL. Patients received BTK inhibitors and/or lenalidomide and its biosimilars after the failure of the first-line standard treatment. The efficacy was evaluated by the investigators. Cohort plans to enroll one hundred patients with BTK inhibitors treatment (excluding the combination with lenalidomide), one hundred patients with lenalidomide treatment (excluding the combination with BTK inhibitors) and any number of the cases with BTK inhibitors and lenalidomide combination. a) BTK inhibitors include ibrutinib, zanubrutinib and acalabrutinib Patients with comprehensive history information and follow-up data. Patient able to provide written informed consent, agreeing that the donated samples and related information can be used for all medical research. Exclusion Criteria: The archived tumor tissue is too little to test. Patients with primary central nerve system large B-cell lymphoma or primary mediastinal large B-cell lymphoma. R/R DLBCL patients receive BTK inhibitor or lenalidomide treatment for less than one cycle.

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 |
| --- | --- |
| Group/Cohort<br>Retrospective Cohort： Participants who diagnosed with relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) patients and treated with BTK inhibitor or lenalidomide and its biosimilars. | Diagnostic Test: Gene expression profile<br>* Diagnostic Test: The Canhelp-COO Assay (Canhelp Genomics CO., Ltd) for differentiating COO subtypes using gene expression analysis by real-time PCR (RT-PCR)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proportion of the cell of origin subtypes in the study population | Investigate the proportion of the cell of origin (COO) subtypes in relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) treated with BTK inhibitor or lenalidomide and its biosimilars. | up to 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| correlation between COO subtypes and the ORR of the treatment of R/R DLBCL. | Based on the objective response rate (ORR) measured by the investigator, explore the correlation between COO subtypes and the efficacy of BTK inhibitors, lenalidomide and its biosimilars in the treatment of R/R DLBCL. | up to 24 weeks | 
| correlation between COO subtypes and the PFS and OS of the treatment of R/R DLBCL. | Based on the progression-free survival (PFS) and overall survival (OS) measuredd by the investigator, explore the correlation between COO subtypes and the efficacy of BTK inhibitors, lenalidomide and its biosimilars in the treatment of R/R DLBCL . | up to 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Canhelp-COO Assay