Lymphoma, Large B-Cell, Diffuse
Conditions
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
Interventions
None listed
Sponsors
Samsung Medical Center
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Next generation sequencing with tumor tissue | 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 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Data which included salvage chemotherapy. | 2-year follow-up from the end of the enrollment | Progression free survival, response rate for salvage chemotherapy. |
| Data which included survival outcome. | 2-year follow-up from the end of the enrollment | Overall survival |
Countries
South Korea
Contacts
Primary ContactWon Seog Kim, MD. PhD
Outcome results
None listed