Biomarkers in Samples From Patients With Follicular Lymphoma Treated With Rituximab

Lymphoma Clinical Trial

Official title:

Identification of Biomarkers Predicting Responsiveness to Rituximab in Follicular Lymphoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01150643
• Other study ID #: CDR0000675681
• Secondary ID: ECOG-E4402T1
• Status: Completed
• Phase: N/A
• First received: June 24, 2010
• Last updated: May 16, 2017
• Start date: December 6, 2010
• Est. completion date: January 6, 2011

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 the effects of rituximab in blood and tumor tissue samples from patients with cancer in the laboratory may help doctors learn more about the effects of rituximab on cancer cells. It may also help doctors identify biomarkers related to cancer.

PURPOSE: This research study is studying biomarkers in samples from patients with follicular lymphoma treated with rituximab.

Description:

OBJECTIVES:

• Correlate immunoglobulin Fc receptor (FcγR) polymorphisms with response, response duration, and time to resistance in samples from patients with follicular lymphoma (FL) treated with single-agent rituximab on ECOG-E4402.

• Identify gene expression profiles that correlate with response, response duration, and time to rituximab resistance in these patients.

• Determine whether the FL microenvironment is predictive of initial response and duration of response to rituximab.

OUTLINE: DNA and RNA from banked peripheral blood mononuclear cells (PBMCs) and formalin-fixed paraffin-embedded (FFPE) tumor samples are analyzed for immunoglobulin-receptor polymorphism, gene expression profile, and follicular lymphoma microenvironment by real-time PCR, microarray hybridization, and IHC.

PROJECTED ACCRUAL: A total of 259 PBMC samples and 300 FFPE blocks will be accrued for this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 559
• Est. completion date: January 6, 2011
• Est. primary completion date: January 6, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

DISEASE CHARACTERISTICS:

• Diagnosed with follicular lymphoma

• Treated on ECOG-E4402 comprising 1 of 2 different rituximab-dose strategies

• Banked peripheral blood mononuclear cells (PBMCs) and formalin-fixed paraffin-embedded (FFPE) tumor samples available

PATIENT CHARACTERISTICS:

• Not specified

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Follicular

Intervention

Genetic:
• gene expression analysis

• microarray analysis

• polymerase chain reaction

• polymorphism analysis

Other:
• immunohistochemistry staining method

• laboratory biomarker analysis

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Eastern Cooperative Oncology Group	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between Fc?R polymorphisms and rituximab response, response duration, and time to resistance		1 month