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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03977623
Other study ID # 2019-04-087
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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