Clinical trial NCT03977623: Genomic Evaluation in Patients With Diffuse Large B Cell Lymphoma After First Relapse/Progression
Official title: Prospective Cohort Study for Genomic Evaluation in Patients With Diffuse Large B Cell Lymphoma After First Relapse/Progression
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lymphoma, Large B-Cell, Diffuse
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2019-06-06
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects-both inpatients and outpatients-will be given an explanation of the significance of this study before recruitment.

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

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

Primary outcomes:
measure: Next generation sequencing with tumor tissue
timeFrame: 2-year follow-up from the end of the enrollment
measure: Next generation sequencing with blood
timeFrame: 2-year follow-up from the end of the enrollment
Secondary outcomes:
measure: Data which included salvage chemotherapy.
timeFrame: 2-year follow-up from the end of the enrollment
measure: Data which included survival outcome.
timeFrame: 2-year follow-up from the end of the enrollment
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References: