S8809-S9800-S9911-S9704-A Study of Blood and Tissue Samples From Patients With Follicular Lymphoma Treated With Rituximab, Cyclophosphamide, Doxorubicin Hydrochloride, Vincristine, and Prednisone
RATIONALE: Studying samples of blood and 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 patients will respond to treatment.
PURPOSE: This research study is looking at blood and tissue samples from patients with follicular lymphoma treated with rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone.
Genetic: DNA analysis
Genetic: polymerase chain reaction
Genetic: polymorphism analysis
Other: laboratory biomarker analysis
|Study Design:||Time Perspective: Retrospective|
|Official Title:||Association of FC-Gamma Receptor Genotypes With Response and Clinical Benefit With Addition of Rituximab to CHOP Chemotherapy in Patients With Follicular Lymphoma (FL)|
- Association of Fc-gamma (Fcγ) receptor genotypes with overall and/or progression-free survival and clinical response [ Time Frame: retrospectively ] [ Designated as safety issue: No ]
- Novel polymorphisms in Fcγ receptors for predictive and prognostic significance [ Time Frame: retrospectively ] [ Designated as safety issue: No ]
|Study Start Date:||December 2008|
|Study Completion Date:||June 2012|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
- To test for association of polymorphisms in Fc-gamma (Fcγ) receptors IIa (H/R131) and IIIa (V/F158) with progression-free survival and clinical response in patients with follicular non-Hodgkin lymphoma treated with rituximab and CHOP chemotherapy comprising cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone.
- To assess novel polymorphisms in Fcγ receptors for predictive and prognostic significance in patients treated with this regimen.
OUTLINE: Genomic DNA extracted from paired samples of serum and formalin-fixed paraffin-embedded tissue is analyzed for R131H polymorphism in Fcγ receptor IIa and V158F polymorphism in Fcγ receptor IIIa by TaqMan-based assay. The DNA is also analyzed for genotypes corresponding with several other polymorphisms in Fcγ receptors, as determined by the HapMap project. The resulting Fcγ receptor genotypes are then compared with clinical data from the Southwest Oncology Group database to identify associations between particular genotypes and progression-free survival, overall response, and complete response. A multivariate analysis incorporating clinical prognostic variables (e.g., age, stage, serum LDH level, extranodal disease, and performance status) is also performed to determine whether Fcγ receptor polymorphisms are independent predictive or prognostic markers for clinical outcome.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00933127
|Study Chair:||Lisa Rimsza, MD||University of Arizona|