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

Fudan University

Status: Completed

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

Treatments: Diagnostic Test: Gene expression profile

Study type: Observational

Funder types: Other

Identifiers

NCT05318391

SHZS-DLBCL001

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 324 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Histologically-confirmed diagnosis of DLBCL, including transformed large B-cell lymphoma from previous indolent lymphoma.

2. Meet the definition of relapsed/refractory DLBCL.

3. 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

4. Patients with comprehensive history information and follow-up data.

5. Patient able to provide written informed consent, agreeing that the donated samples and related information can be used for all medical research.

Exclusion criteria

1. The archived tumor tissue is too little to test.
2. Patients with primary central nerve system large B-cell lymphoma or primary mediastinal large B-cell lymphoma.
3. R/R DLBCL patients receive BTK inhibitor or lenalidomide treatment for less than one cycle.

Trial design

324 participants in 1 patient group

Group/Cohort

Description:

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.

Treatment:

Diagnostic Test: Gene expression profile