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Association of FC-Gamma Receptor Genotypes With Response and Clinical Benefit With Addition of Rituximab to CHOP Chemotherapy in Patients With Follicular Lymphoma (FL)


N/A
16 Years
N/A
Not Enrolling
Both
Lymphoma

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Trial Information

Association of FC-Gamma Receptor Genotypes With Response and Clinical Benefit With Addition of Rituximab to CHOP Chemotherapy in Patients With Follicular Lymphoma (FL)


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.

Inclusion Criteria


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

Type of Study:

Observational

Study Design:

N/A

Outcome Measure:

Association of Fc-gamma (Fcγ) receptor genotypes with overall and/or progression-free survival and clinical response

Safety Issue:

No

Principal Investigator

Lisa Rimsza, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Arizona

Authority:

Unspecified

Study ID:

CDR0000630578

NCT ID:

NCT00933127

Start Date:

December 2008

Completion Date:

Related Keywords:

  • Lymphoma
  • contiguous stage II grade 1 follicular lymphoma
  • contiguous stage II grade 2 follicular lymphoma
  • contiguous stage II grade 3 follicular lymphoma
  • noncontiguous stage II grade 1 follicular lymphoma
  • noncontiguous stage II grade 2 follicular lymphoma
  • noncontiguous stage II 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
  • stage IV grade 3 follicular lymphoma
  • Lymphoma
  • Lymphoma, Follicular

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