Analysis of E4494 Tissues to Determine the Prognostic Significance of Biomarkers in Diffuse Large B Cell Lymphoma (DLBCL) Treated With Standard Chemotherapy (CHOP) Plus Rituximab ®)1
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 1,600
- Primary Endpoint
- Correlation of biomarkers with response and outcome
Study Overview
Brief Summary
RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. It may also help doctors understand how patients respond to treatment.
PURPOSE: This laboratory study is looking at biomarkers using tissue samples from older patients with diffuse large B-cell lymphoma treated with combination chemotherapy with or without rituximab on clinical trial ECOG-E4494.
Detailed Description
OBJECTIVES:
- To construct tissue microarrays (TMA) using tissue samples from older patients with diffuse large B-cell lymphoma treated with standard CHOP chemotherapy (cyclophosphamide, doxorubicin, vincristine, and prednisone) with or without rituximab on clinical trial ECOG-E4494.
- To allow this TMA resource to be included in a large international effort (the Lunenburg Lymphoma Biomarker Consortium [LLBC]), partnering with several other similar randomized trials (EORTC, HOVON, GELA, MINT) in order to properly power and bring standardization to the study of biomarkers in lymphoma.
- To evaluate the clinical impact and prognostic importance of a number of biomarkers, including Bcl-2, Bcl-6, CD10, FOXP1, MUM1, Ki-67, CD5, and HLA-Dr.
- To determine the prognostic impact of clinical International Prognostic Index (IPI) variables in a large international study.
- To determine the relationship between different biomarkers and clinical predictors.
- To establish the TMA (using tissue samples from patients treated on clinical trial ECOG-E4494) as a resource for future ECOG-driven studies and for validation of novel biomarkers as they become recognized and available.
OUTLINE: Patients are stratified according to prior treatment (CHOP chemotherapy [cyclophosphamide, doxorubicin, vincristine, and prednisone] or CHOP-like chemotherapy vs CHOP chemotherapy with or without rituximab).
Tissue microarrays will be constructed using tissue samples previously collected from patients treated on clinical trial ECOG-E4494. Tissue microarrays will be used for biomarker studies.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 60 Years to 120 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Correlation of biomarkers with response and outcome
Time Frame: 1 month
Secondary Outcomes
No secondary outcomes reported