Lymphoma, Large B-Cell, DiffuseCOGET-BNCT03977623
Genomic Evaluation in Patients With Diffuse Large B Cell Lymphoma After First Relapse/Progression
An observational study of Lymphoma, Large B-Cell, Diffuse, run by Samsung Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Large B-Cell, Diffuse
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- 24 Sep 2019to 28 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects-both inpatients and outpatients-will be given an explanation of the significance of this study before recruitment.
Who may be able to join
- 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
Who cannot join
- No lymphoid malignancy, e.g. myeloid leukemia
- Any of the following lymphoid malignancies:
- Plasma cell dyscrasia, amyloidosis
- Hodgkin lymphoma
- Subtypes of B cell non-Hodgkin lymphoma, other than DLBCL
- T or NK(Natural Killer) cell non-Hodgkin lymphoma
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, 06351
Won Seog Kim, Professor
About this study
Official title: 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.
Read the 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
- Conditions
- Lymphoma, Large B-Cell, Diffuse
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What is being measured
The primary outcome is the main question the study is designed to answer.
Next generation sequencing with tumor tissue
To understand the mechanism of relapse, targeted sequencing based on HemaScan panel including the essential genes (including 425 whole exome).
Measured: 2-year follow-up from the end of the enrollment
Next generation sequencing with blood
To understand the mechanism of relapse, targeted sequencing based on HemaScan panel including the essential genes (including 425 whole exome).
Measured: 2-year follow-up from the end of the enrollment
Secondary outcomes (2)
Data which included salvage chemotherapy.
Progression free survival, response rate for salvage chemotherapy.
Measured: 2-year follow-up from the end of the enrollment
Data which included survival outcome.
Overall survival
Measured: 2-year follow-up from the end of the enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2019
- Study start24 Sep 2019
- Primary completion28 Feb 2022 (estimated)
- Study completion28 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, Large B-Cell, DiffuseStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Won Seog Kim, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03977623
- Sponsor's protocol ID
- 2019-04-087
- Acronym
- COGET-B
- Status last verified
- Mar 2020
- First submitted
- 17 May 2019
- Last updated
- 18 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: * 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.
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Study for Genomic Evaluation in Patients With Diffuse Large B Cell Lymphoma After First Relapse/Progression
- ClinicalTrials.gov ID
- NCT03977623
- Acronym / sponsor ID
- COGET-B / 2019-04-087
- Conditions
- Lymphoma, Large B-Cell, Diffuse
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 24 Sep 2019 (actual)
- Primary completion
- 28 Feb 2022 (estimated)
- Study completion
- 28 Feb 2022 (estimated)
- First posted
- 6 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects-both inpatients and outpatients-will be given an explanation of the significance of this study before recruitment.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- No lymphoid malignancy, e.g. myeloid leukemia
- Any of the following lymphoid malignancies:
- Experienced a relapse before
- Insufficient or no tissue sample at diagnosis for genomic analysis
- Can not understand or provide written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
2 secondary outcomes
Data which included salvage chemotherapy.
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2020.
- Individual participant dataSharing planned: No. * 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphoma, Large B-Cell, Diffuse, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Won Seog Kim, MD. PhD (82-2-3410-6548, wonseog.kim@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Next generation sequencing with tumor tissue (time frame: 2-year follow-up from the end of the enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2020.