Biomarkers in Patients With Diffuse Large B-Cell Lymphoma Treated With Combination Chemotherapy With or Without Rituximab

Lymphoma Clinical Trial

Official title:

Gene Expression Profiling Using Paraffin-embedded Tissues and the Nuclease Protection Assay in Diffuse Large B-cell Lymphoma (DLBCL) Treated With CHOP or R-CHOP: An ECOG and SWOG Correlative Study of E4494

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01131208
• Other study ID #: CDR0000671515
• Secondary ID: ECOG-E4494T2
• Status: Completed
• Phase: N/A
• First received: May 25, 2010
• Last updated: May 16, 2017
• Start date: April 21, 2010
• Est. completion date: August 21, 2010

Study information

• Verified date: May 2017
• Source: Eastern Cooperative Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 predict how well patients will respond to treatment.

PURPOSE: This research study is studying biomarkers in patients with diffuse large B-cell lymphoma treated with combination chemotherapy with or without rituximab.

Description:

OBJECTIVES:

• To identify genes predictive of clinical outcome (failure-free survival and overall survival) among patients with diffuse large B-cell lymphoma treated with CHOP or R-CHOP induction on ECOG-E4494 using the nuclease protection assay for measuring gene expression in paraffin-embedded tissue.

• To identify genes that change their prognostic profile with the addition of rituximab to CHOP chemotherapy.

OUTLINE: This is a multicenter study.

Unstained formalin-fixed, paraffin-embedded samples are analyzed for gene expression via nuclease protection assay.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: August 21, 2010
• Est. primary completion date: August 21, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 120 Years

Eligibility

DISEASE CHARACTERISTICS:

• Diagnosis of diffuse large B-cell lymphoma

• Treated with CHOP or R-CHOP on ECOG-E4494

PATIENT CHARACTERISTICS:

• Not specified

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Intervention

Genetic:
• gene expression analysis

Other:
• laboratory biomarker analysis

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
ECOG-ACRIN Cancer Research Group	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of genes predictive of clinical outcome		1 month
Primary	Identification of genes that change their prognostic profile with the addition of rituximab to CHOP chemotherapy		1 month