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

Lymphoma, Large B-Cell, Diffuse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05318391
• Other study ID #: SHZS-DLBCL001
• Status: Completed
• Start date: April 14, 2021
• Est. completion date: March 30, 2022

Study information

• Verified date: March 2022
• Source: Shanghai Zhongshan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 324
• Est. completion date: March 30, 2022
• Est. primary completion date: January 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Diagnostic Test:
• Gene expression profile
Diagnostic Test: The Canhelp-COO Assay (Canhelp Genomics CO., Ltd) for differentiating COO subtypes using gene expression analysis by real-time PCR (RT-PCR)

Locations

Country	Name	City	State
China	Yian Zhang	Shanghai	Shanghai

Sponsors (3)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital	Shanghai Minhang Central Hospital, Wuxi People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

Yan WH, Jiang XN, Wang WG, Sun YF, Wo YX, Luo ZZ, Xu QH, Zhou XY, Cao JN, Hong XN, Li XQ. Cell-of-Origin Subtyping of Diffuse Large B-Cell Lymphoma by Using a qPCR-based Gene Expression Assay on Formalin-Fixed Paraffin-Embedded Tissues. Front Oncol. 2020 Jun 5;10:803. doi: 10.3389/fonc.2020.00803. eCollection 2020. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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