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
NCT ID: NCT00933127
Last Updated: 2014-07-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
142 participants
OBSERVATIONAL
2008-12-31
2012-06-30
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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RETROSPECTIVE
Interventions
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DNA analysis
polymerase chain reaction
polymorphism analysis
laboratory biomarker analysis
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of follicular lymphoma
* Meets either of the following criteria:
* Previously enrolled on clinical trial SW0G-8809 and treated with chemotherapy alone
* Excess tissue sections available
* Previously enrolled on clinical trial SWOG-9800 or SWOG-9911 and treated with a combination of chemotherapy and monoclonal antibody therapy
* Matched serum and tissue samples available from the SWOG Lymphoma Bank
PATIENT CHARACTERISTICS:
* See Disease Characteristics
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
SWOG Cancer Research Network
NETWORK
Responsible Party
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Principal Investigators
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Lisa Rimsza, MD
Role: STUDY_CHAIR
University of Arizona
References
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Persky DO, Dornan D, Goldman BH, Braziel RM, Fisher RI, Leblanc M, Maloney DG, Press OW, Miller TP, Rimsza LM. Fc gamma receptor 3a genotype predicts overall survival in follicular lymphoma patients treated on SWOG trials with combined monoclonal antibody plus chemotherapy but not chemotherapy alone. Haematologica. 2012 Jun;97(6):937-42. doi: 10.3324/haematol.2011.050419. Epub 2012 Jan 22.
Other Identifiers
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SWOG-S8809-S9800-S9911-S9704-A
Identifier Type: -
Identifier Source: secondary_id
CDR0000630578
Identifier Type: -
Identifier Source: org_study_id
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