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

• Conditions: Lymphoma, Large B-Cell, Diffuse

• Registration Number: NCT03977623
• Lead Sponsor: Samsung Medical Center

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

Study Timeline

• Study First Submitted: 2019-05-17
• Study First Submitted QC: 2019-06-04
• Study First Posted: 2019-06-06
• Study Start: 2019-09-24
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-16
• Last Update Posted: 2020-03-18
• Primary Completion: 2022-02-28
• Study Completion: 2022-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of