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

Completed

• Conditions: Lymphoma, Large B-Cell, Diffuse; Gene Expression Profiling
• Interventions: Diagnostic Test: Gene expression profile

• Registration Number: NCT05318391
• Lead Sponsor: Shanghai Zhongshan Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2021-04-14
• Study First Submitted: 2021-05-08
• Primary Completion: 2022-01-30
• Status Verified: 2022-03
• Study Completion: 2022-03-30
• Study First Submitted QC: 2022-03-31
• Last Update Submitted: 2022-03-31
• Study First Posted: 2022-04-08
• Last Update Posted: 2022-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 324

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group/Cohort	Gene expression profile	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.

Primary Outcome Measures

Name	Time	Method
proportion of the cell of origin subtypes in the study population	up to 24 weeks	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.

Secondary Outcome Measures

Name	Time	Method
correlation between COO subtypes and the ORR of the treatment of R/R DLBCL.	up to 24 weeks	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.
correlation between COO subtypes and the PFS and OS of the treatment of R/R DLBCL.	up to 24 weeks	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 .

Trial Locations

Locations (1)

Yian Zhang; 🇨🇳 Shanghai, Shanghai, China