Biomarkers in Predicting Response to Rituximab Treatment in Samples From Patients With Indolent Follicular Lymphoma

Validating the Predictive Value (of Response to Rituximab Induction and Maintenance) of the FCGR3A 158V/F Polymorphism Using Complimentary Genotyping Methods

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01381705

Enrollment

259

Registered

2011-06-27

Start date

2012-02-06

Completion date

2012-07-06

Last updated

2017-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphoma

Keywords

recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma

Brief summary

RATIONALE: Studying samples of blood and tumor 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 well patients will respond to treatment. PURPOSE: This research study is studying biomarkers in predicting response to rituximab treatment in samples from patients with indolent follicular lymphoma.

Detailed description

OBJECTIVES: Primary * Genotype the full cohort of samples available from the RESORT clinical trial (ECOG-E4402) for FCGR3A 158V/F in parallel to independently verify results. * Correlate the FCGR3A 158V/F polymorphisms to response, response duration, and time to rituximab resistance. Secondary * Quantify copy number variation in FCGR3A in this cohort. OUTLINE: Archived DNA samples isolate from peripheral blood mononuclear cells and from formalin-fixed paraffin-embedded tissue samples are analyzed for FCGR3A 158V/F polymorphisms using different complementary genotyping methods. Assay results are reviewed and compared with patients' outcome data.

Interventions

BIOLOGICALrituximab

GENETICDNA analysis

GENETICgene expression analysis

GENETICpolymorphism analysis

OTHERlaboratory biomarker analysis

OTHERmedical chart review

Study design

Observational model

OTHER

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 120 Years

Healthy volunteers

Inclusion criteria

DISEASE CHARACTERISTICS: * Diagnosed with indolent follicular lymphoma * Treated on RESORT trial (ECOG-E4402) comprising rituximab monotherapy and then randomized to rituximab maintenance therapy or retreatment with rituximab upon disease relapse * Blood and tissue samples from patients available PATIENT CHARACTERISTICS: * Not specified PRIOR CONCURRENT THERAPY: * See Disease Characteristics

Design outcomes

Primary

Measure	Time frame
Correlation of FCGR3A 158V/F polymorphisms with response, duration of response, and time to rituximab resistance	1 year

Secondary

Measure	Time frame
Copy number variation in FCGR3A cohort	1 year

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026