Biomarkers in Predicting Response to Rituximab Treatment in Samples From Patients With Indolent Follicular Lymphoma
|ClinicalTrials.gov Identifier: NCT01381705|
Recruitment Status : Completed
First Posted : June 27, 2011
Last Update Posted : May 17, 2017
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.
|Condition or disease||Intervention/treatment|
|Lymphoma||Biological: rituximab Genetic: DNA analysis Genetic: gene expression analysis Genetic: polymorphism analysis Other: laboratory biomarker analysis Other: medical chart review|
- 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.
- 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.
|Study Type :||Observational|
|Actual Enrollment :||259 participants|
|Official Title:||Validating the Predictive Value (of Response to Rituximab Induction and Maintenance) of the FCGR3A 158V/F Polymorphism Using Complimentary Genotyping Methods|
|Actual Study Start Date :||February 6, 2012|
|Actual Primary Completion Date :||July 6, 2012|
|Actual Study Completion Date :||July 6, 2012|
- Correlation of FCGR3A 158V/F polymorphisms with response, duration of response, and time to rituximab resistance [ Time Frame: 1 year ]
- Copy number variation in FCGR3A cohort [ Time Frame: 1 year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01381705
|Principal Investigator:||Brad S. Kahl, MD||University of Wisconsin, Madison|