Trial Information

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

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.