4006-776-356 出国就医服务电话

免费获得国外相关药品，最快 1 个工作日回馈药物信息

出境医 / 临床实验 / Genomic Evaluation in Patients With Diffuse Large B Cell Lymphoma After First Relapse/Progression (COGET-B)

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

Study Description
Brief Summary:
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.

Condition or disease
Lymphoma, Large B-Cell, Diffuse

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 Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Prospective Cohort Study for Genomic Evaluation in Patients With Diffuse Large B Cell Lymphoma After First Relapse/Progression
Actual Study Start Date : September 24, 2019
Estimated Primary Completion Date : February 28, 2022
Estimated Study Completion Date : February 28, 2022
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. 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. 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).


Secondary Outcome Measures :
  1. 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. Data which included survival outcome. [ Time Frame: 2-year follow-up from the end of the enrollment ]
    Overall survival


Biospecimen Retention:   Samples With DNA
  1. Blood sample : SST(Serum Separation Tube) 3ml, EDTA (Ethylenediaminetetraacetic Acid) 3ml
  2. Tissue : unstained slides ((at least) 5 slides with a thickness of 5 microns)

Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Subjects-both inpatients and outpatients-will be given an explanation of the significance of this study before recruitment.
Criteria

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
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Won Seog Kim, MD. PhD 82-2-3410-6548 wonseog.kim@samsung.com

Locations
Layout table for location information
Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 06351
Contact: Won Seog Kim, Professor         
Sponsors and Collaborators
Samsung Medical Center
Tracking Information
First Submitted Date May 17, 2019
First Posted Date June 6, 2019
Last Update Posted Date March 18, 2020
Actual Study Start Date September 24, 2019
Estimated Primary Completion Date February 28, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 4, 2019)
  • 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).
  • 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).
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 4, 2019)
  • 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.
  • Data which included survival outcome. [ Time Frame: 2-year follow-up from the end of the enrollment ]
    Overall survival
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Genomic Evaluation in Patients With Diffuse Large B Cell Lymphoma After First Relapse/Progression
Official Title Prospective Cohort Study for Genomic Evaluation in Patients With Diffuse Large B Cell Lymphoma After First Relapse/Progression
Brief Summary 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.
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
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
  1. Blood sample : SST(Serum Separation Tube) 3ml, EDTA (Ethylenediaminetetraacetic Acid) 3ml
  2. Tissue : unstained slides ((at least) 5 slides with a thickness of 5 microns)
Sampling Method Probability Sample
Study Population Subjects-both inpatients and outpatients-will be given an explanation of the significance of this study before recruitment.
Condition Lymphoma, Large B-Cell, Diffuse
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 4, 2019) 		200
Original Estimated Enrollment Same as current
Estimated Study Completion Date February 28, 2022
Estimated Primary Completion Date February 28, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Won Seog Kim, MD. PhD 82-2-3410-6548 wonseog.kim@samsung.com
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT03977623
Other Study ID Numbers 2019-04-087
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
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.
Responsible Party Won Seog Kim, Samsung Medical Center
Study Sponsor Samsung Medical Center
Collaborators Not Provided
Investigators Not Provided
PRS Account Samsung Medical Center
Verification Date March 2020

治疗医院

新药特效药

治疗案例

前沿医讯