- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00933127
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
Association of FC-Gamma Receptor Genotypes With Response and Clinical Benefit With Addition of Rituximab to CHOP Chemotherapy in Patients With Follicular Lymphoma (FL)
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.
Study Overview
Status
Conditions
Detailed Description
OBJECTIVES:
- 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
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
DISEASE CHARACTERISTICS:
- 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
Study Plan
How is the study designed?
Design Details
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Association of Fc-gamma (Fcγ) receptor genotypes with overall and/or progression-free survival and clinical response
Time Frame: retrospectively
|
retrospectively
|
Novel polymorphisms in Fcγ receptors for predictive and prognostic significance
Time Frame: retrospectively
|
retrospectively
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- stage IV grade 3 follicular lymphoma
- stage III grade 1 follicular lymphoma
- stage III grade 2 follicular lymphoma
- stage III grade 3 follicular lymphoma
- stage IV grade 1 follicular lymphoma
- stage IV grade 2 follicular lymphoma
- contiguous stage II grade 1 follicular lymphoma
- contiguous stage II grade 2 follicular lymphoma
- noncontiguous stage II grade 1 follicular lymphoma
- noncontiguous stage II grade 2 follicular lymphoma
- noncontiguous stage II grade 3 follicular lymphoma
- contiguous stage II grade 3 follicular lymphoma
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000630578
- SWOG-S8809-S9800-S9911-S9704-A
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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