Genomic Evaluation in Patients With Diffuse Large B Cell Lymphoma After First Relapse/Progression

Lymphoma, Large B-Cell, Diffuse Clinical Trial

— COGET-B  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03977623
• Other study ID #: 2019-04-087
• Status: Recruiting
• Start date: September 24, 2019
• Est. completion date: February 28, 2022

Study information

• Verified date: March 2020
• Source: Samsung Medical Center
• Contact: Won Seog Kim, MD. PhD
• Phone: 82-2-3410-6548
• Email: wonseog.kim[@]samsung.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: February 28, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	2-year follow-up from the end of the enrollment
Primary	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).	2-year follow-up from the end of the enrollment
Secondary	Data which included salvage chemotherapy.	Progression free survival, response rate for salvage chemotherapy.	2-year follow-up from the end of the enrollment
Secondary	Data which included survival outcome.	Overall survival	2-year follow-up from the end of the enrollment