Study of 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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2007 by National Cancer Institute (NCI).
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00898157
First received: May 9, 2009
Last updated: NA
Last verified: December 2007
History: No changes posted
  Purpose

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.


Condition Intervention
Lymphoma
Other: laboratory biomarker analysis

Study Type: Observational
Official Title: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Construction of tissue microarrays (TMA) [ Designated as safety issue: No ]
  • Include this TMA resource in the Lunenburg Lymphoma Biomarker Consortium [ Designated as safety issue: No ]
  • Clinical impact and prognostic importance of a number of biomarkers, including Bcl-2, Bcl-6, CD10, FOXP1, MUM1, Ki-67, CD5, and HLA-Dr [ Designated as safety issue: No ]
  • Prognostic impact of clinical International Prognostic Index (IPI) variables [ Designated as safety issue: No ]
  • Relationship between different biomarkers and clinical predictors [ Designated as safety issue: No ]
  • Establishment of the TMA (using tissue samples from patients treated on clinical trial ECOG-E4494) as a resource for future studies and for validation of novel biomarkers as they become recognized and available [ Designated as safety issue: No ]

Estimated Enrollment: 1600
Study Start Date: September 2007
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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of diffuse large B-cell lymphoma
  • Received treatment on clinical trial ECOG-E4494

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00898157

Sponsors and Collaborators
Eastern Cooperative Oncology Group
Investigators
Study Chair: Randall D. Gascoyne, MD British Columbia Cancer Agency
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00898157     History of Changes
Other Study ID Numbers: CDR0000571530, ECOG-E4494T1
Study First Received: May 9, 2009
Last Updated: May 9, 2009
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
contiguous stage II adult diffuse large cell lymphoma
noncontiguous stage II adult diffuse large cell lymphoma
recurrent adult diffuse large cell lymphoma
stage I adult diffuse large cell lymphoma
stage III adult diffuse large cell lymphoma
stage IV adult diffuse large cell lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Rituximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on August 26, 2014