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

Sponsor

Southwest Oncology Group (Other)

Overall Status

Completed

CT.gov ID

NCT00933127

Collaborator

National Cancer Institute (NCI) (NIH)

142

Enrollment

Duration (Months)

Study Details

Study Description

Brief Summary

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	Phase
Lymphoma	Genetic: DNA analysis Genetic: polymerase chain reaction Genetic: polymorphism analysis Other: laboratory biomarker analysis

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 Design

Study Type:

Observational

Actual Enrollment :

142 participants

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)

Study Start Date :

Dec 1, 2008

Actual Primary Completion Date :

Jun 1, 2012

Actual Study Completion Date :

Jun 1, 2012

Outcome Measures

Primary Outcome Measures

Association of Fc-gamma (Fcγ) receptor genotypes with overall and/or progression-free survival and clinical response [retrospectively]
Novel polymorphisms in Fcγ receptors for predictive and prognostic significance [retrospectively]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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