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

NCT ID: NCT03977623

Last Updated: 2020-03-18

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-09-24
• Study Completion Date: 2022-02-28

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

Conditions

Lymphoma, Large B-Cell, Diffuse

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Samsung Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Won Seog Kim

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Samsung Medical Center

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Won Seog Kim, MD. PhD

Role: CONTACT

wonseog.kim@samsung.com

82-2-3410-6548

Facility Contacts

Won Seog Kim, Professor

Role: primary

Other Identifiers

2019-04-087

Identifier Type: -

Identifier Source: org_study_id