NCT01381705

Biomarkers in Predicting Response to Rituximab Treatment in Samples From Patients With Indolent Follicular Lymphoma

Validating the Predictive Value (of Response to Rituximab Induction and Maintenance) of the FCGR3A 158V/F Polymorphism Using Complimentary Genotyping Methods

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 259 (actual)
• Sponsor: ECOG-ACRIN Cancer Research Group · Network
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Studying samples of blood and tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify 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 predicting response to rituximab treatment in samples from patients with indolent follicular lymphoma.

Detailed description

OBJECTIVES: Primary * Genotype the full cohort of samples available from the RESORT clinical trial (ECOG-E4402) for FCGR3A 158V/F in parallel to independently verify results. * Correlate the FCGR3A 158V/F polymorphisms to response, response duration, and time to rituximab resistance. Secondary * Quantify copy number variation in FCGR3A in this cohort. OUTLINE: Archived DNA samples isolate from peripheral blood mononuclear cells and from formalin-fixed paraffin-embedded tissue samples are analyzed for FCGR3A 158V/F polymorphisms using different complementary genotyping methods. Assay results are reviewed and compared with patients' outcome data.

Conditions

• Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	rituximab
GENETIC	DNA analysis
GENETIC	gene expression analysis
GENETIC	polymorphism analysis
OTHER	laboratory biomarker analysis
OTHER	medical chart review

Timeline

• Start date: 2012-02-06
• Primary completion: 2012-07-06
• Completion: 2012-07-06
• First posted: 2011-06-27
• Last updated: 2017-05-17