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
|ClinicalTrials.gov Identifier: NCT00933127|
Recruitment Status : Completed
First Posted : July 7, 2009
Last Update Posted : July 24, 2014
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.
|Condition or disease||Intervention/treatment|
|Lymphoma||Genetic: DNA analysis Genetic: polymerase chain reaction Genetic: polymorphism analysis Other: laboratory biomarker analysis|
- 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.
|Study Type :||Observational|
|Actual Enrollment :||142 participants|
|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)|
|Study Start Date :||December 2008|
|Primary Completion Date :||June 2012|
|Study Completion Date :||June 2012|
- Association of Fc-gamma (Fcγ) receptor genotypes with overall and/or progression-free survival and clinical response [ Time Frame: retrospectively ]
- Novel polymorphisms in Fcγ receptors for predictive and prognostic significance [ Time Frame: retrospectively ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00933127
|Study Chair:||Lisa Rimsza, MD||University of Arizona|