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

Sponsor
Shanghai Zhongshan Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05318391
Collaborator
Wuxi People's Hospital (Other), Shanghai Minhang Central Hospital (Other)
324
Enrollment
1
Location
11.5
Actual Duration (Months)
28.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Diagnostic Test: Gene expression profile

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 Design

Study Type:
Observational
Actual Enrollment :
324 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Translational Study of Molecular Classification of Relapsed/Refractory Diffuse Large B-cell Lymphoma
Actual Study Start Date :
Apr 14, 2021
Actual Primary Completion Date :
Jan 30, 2022
Actual Study Completion Date :
Mar 30, 2022

Arms and Interventions

ArmIntervention/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)

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. 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 .

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

  1. BTK inhibitors include ibrutinib, zanubrutinib and acalabrutinib
  1. Patients with comprehensive history information and follow-up data.

  2. 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.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Yian ZhangShanghaiShanghaiChina200032

Sponsors and Collaborators

  • Shanghai Zhongshan Hospital
  • Wuxi People's Hospital
  • Shanghai Minhang Central Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Peng Liu, Chief of hematology department, Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier:
NCT05318391
Other Study ID Numbers:
  • SHZS-DLBCL001
First Posted:
Apr 8, 2022
Last Update Posted:
Apr 8, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Peng Liu, Chief of hematology department, Shanghai Zhongshan Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 8, 2022