Biomarkers in Samples From Patients With Follicular Lymphoma Treated With Rituximab
|ClinicalTrials.gov Identifier: NCT01150643|
Recruitment Status : Completed
First Posted : June 25, 2010
Last Update Posted : May 17, 2017
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.
|Condition or disease||Intervention/treatment|
|Lymphoma||Genetic: gene expression analysis Genetic: microarray analysis Genetic: polymerase chain reaction Genetic: polymorphism analysis Other: immunohistochemistry staining method Other: laboratory biomarker analysis|
- 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.
|Study Type :||Observational|
|Actual Enrollment :||559 participants|
|Official Title:||Identification of Biomarkers Predicting Responsiveness to Rituximab in Follicular Lymphoma|
|Actual Study Start Date :||December 6, 2010|
|Primary Completion Date :||January 6, 2011|
|Study Completion Date :||January 6, 2011|
- Correlation between FcγR polymorphisms and rituximab response, response duration, and time to resistance [ Time Frame: 1 month ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01150643
|Principal Investigator:||Brad S. Kahl, MD||University of Wisconsin, Madison|