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

Samsung Medical Center

Status: Unknown

Conditions: Lymphoma, Large B-Cell, Diffuse

Study type: Observational

Funder types: Other

Identifiers

NCT03977623

2019-04-087

Details and patient eligibility

About

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.

Full 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

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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