Genomic Evaluation in Patients With Diffuse Large B Cell Lymphoma After First Relapse/Progression (COGET-B)

March 16, 2020 updated by: Won Seog Kim, Samsung Medical Center

Prospective Cohort Study for Genomic Evaluation in Patients With Diffuse Large B Cell Lymphoma After First Relapse/Progression

DLBCL has the highest frequency out of all lymphoid malignancies. With the recent development of antitumor agents targeting intracellular/extracellular cell signaling pathways, patients have access to various treatment options after relapse. Therefore, for the purpose of developing effective treatment strategies, large-scale genomic data accumulation is necessary to understand the mechanism of relapse and refractory state of DLBCL.

Study Overview

Status

Unknown

Conditions

Detailed Description

  • To understand the mechanism of relapse by genome sequencing with tissues/blood obtained at diagnosis and relapse in patients with diffuse B cell lymphoma who relapsed after standard chemotherapy, to evaluate their response and survival following a salvage therapy depending on the genomic sequencing results, and to understand the prognostic or predictive value of genomic mutation.
  • To understand the predictive value of genetic information with regard to the response to salvage chemotherapy and survival outcome in patients with newly diagnosed/relapsed or refractory large B cell lymphoma
  • To determine the association between gene mutation, treatment response and prognosis in relapsed/refractory diffuse large B cell lymphoma (DLBCL), and to develop a clinically applicable platform by establishing a genetic data register based on prospective studies

Study Type

Observational

Enrollment (Anticipated)

200

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

  • Korea, Republic of
      • Seoul, Korea, Republic of, 06351
        • Recruiting
        • Samsung Medical Center
        • Contact:
          • Won Seog Kim, Professor

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

Probability Sample

Study Population

Subjects-both inpatients and outpatients-will be given an explanation of the significance of this study before recruitment.

Description

Inclusion Criteria:

  • Histopathologically confirmed DLBCL
  • DLBCL who relapsed or were refractory to first-line treatment with rituximab-based immunotherapy
  • Available for genomic analysis of tissues both at diagnosis (paraffin-embedded and stored) and at relapse (paraffin-embedded)
  • Aged ≥18 years
  • Written informed consent for participation in the prospective cohort study
  • Written informed consent to peripheral blood collection and genetic testing of human tissues

Exclusion Criteria:

  • No lymphoid malignancy, e.g. myeloid leukemia

  • Any of the following lymphoid malignancies:

    1. Plasma cell dyscrasia, amyloidosis
    2. Hodgkin lymphoma
    3. Subtypes of B cell non-Hodgkin lymphoma, other than DLBCL
    4. T or NK(Natural Killer) cell non-Hodgkin lymphoma
    5. Other diseases in the WHO(World Health Organization) classification of lymphoid malignancies
  • Experienced a relapse before
  • Insufficient or no tissue sample at diagnosis for genomic analysis
  • Can not understand or provide written informed consent
  • Who do not provide written informed consent to blood collection and genetic testing

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Next generation sequencing with tumor tissue
Time Frame: 2-year follow-up from the end of the enrollment
To understand the mechanism of relapse, targeted sequencing based on HemaScan panel including the essential genes (including 425 whole exome).
2-year follow-up from the end of the enrollment
Next generation sequencing with blood
Time Frame: 2-year follow-up from the end of the enrollment
To understand the mechanism of relapse, targeted sequencing based on HemaScan panel including the essential genes (including 425 whole exome).
2-year follow-up from the end of the enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Data which included salvage chemotherapy.
Time Frame: 2-year follow-up from the end of the enrollment
Progression free survival, response rate for salvage chemotherapy.
2-year follow-up from the end of the enrollment
Data which included survival outcome.
Time Frame: 2-year follow-up from the end of the enrollment
Overall survival
2-year follow-up from the end of the enrollment

Collaborators and Investigators

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

Sponsor

Samsung Medical Center

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)

September 24, 2019

Primary Completion (Anticipated)

February 28, 2022

Study Completion (Anticipated)

February 28, 2022

Study Registration Dates

First Submitted

May 17, 2019

First Submitted That Met QC Criteria

June 4, 2019

First Posted (Actual)

June 6, 2019

Study Record Updates

Last Update Posted (Actual)

March 18, 2020

Last Update Submitted That Met QC Criteria

March 16, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-04-087

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

  • Data management of this clinical trial should be done in accordance with the ICH(International Conference on Harmonization)-GCP(Good Clinical Practice) and KGCP (Korean Good Clinical Practice)guidelines. To ensure the anonymity of subjects, each subject will be identified and managed by a randomly assigned subject number, instead of his/her name, in all documents so that persons not involved in the study could not identify subjects from their personal data.
  • Subjects participating in this clinical trial may have to provide some of their personal information, but such information will not be directly used or necessary in the study but will be used only for the purpose of connecting clinical data obtained for the clinical trial. Collected information will be used until the clinical trial report is complete.

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.

Clinical Trials on Lymphoma, Large B-Cell, Diffuse

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