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

March 31, 2022 updated by: Peng Liu, Shanghai Zhongshan Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

324

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Yian Zhang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Relapsed/refractory DLBCL patients who had received BTK inhibitors and/or lenalidomide and its biosimilars after the failure of the first-line standard treatment.Patients with comprehensive history information and follow-up data and are able to provide written informed consent, agreeing that the donated samples and related information can be used for all medical research.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group/Cohort
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

Diagnostic Test:

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
proportion of the cell of origin subtypes in the study population
Time Frame: 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.
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.
Time Frame: 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.
up to 24 weeks
correlation between COO subtypes and the PFS and OS of the treatment of R/R DLBCL.
Time Frame: 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 .
up to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Zhongshan Hospital

Collaborators

Wuxi People's Hospital
Shanghai Minhang Central Hospital

Investigators

  • Principal Investigator: Peng Liu, MD,PhD, Fudan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 14, 2021

Primary Completion (Actual)

January 30, 2022

Study Completion (Actual)

March 30, 2022

Study Registration Dates

First Submitted

May 8, 2021

First Submitted That Met QC Criteria

March 31, 2022

First Posted (Actual)

April 8, 2022

Study Record Updates

Last Update Posted (Actual)

April 8, 2022

Last Update Submitted That Met QC Criteria

March 31, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHZS-DLBCL001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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