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

Lymphoma Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00933127
• Other study ID #: CDR0000630578
• Secondary ID: SWOG-S8809-S9800
• Status: Completed
• Phase: N/A
• First received: July 3, 2009
• Last updated: July 23, 2014
• Start date: December 2008
• Est. completion date: June 2012

Study information

• Verified date: July 2014
• Source: Southwest Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Follicular

Intervention

Genetic:
• DNA analysis

• polymerase chain reaction

• polymorphism analysis

Other:
• laboratory biomarker analysis

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Southwest Oncology Group	National Cancer Institute (NCI)

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Association of Fc-gamma (Fc?) receptor genotypes with overall and/or progression-free survival and clinical response		retrospectively	No
Primary	Novel polymorphisms in Fc? receptors for predictive and prognostic significance		retrospectively	No

External Links

•   Clinical trial summary from the National Cancer Institute's PDQ® database