Biomarkers in Samples From Patients With Follicular Lymphoma Treated With Rituximab

Identification of Biomarkers Predicting Responsiveness to Rituximab in Follicular Lymphoma

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01150643

Enrollment

559

Registered

2010-06-25

Start date

2010-12-06

Completion date

2011-01-06

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

stage III grade 1 follicular lymphoma, stage III grade 2 follicular lymphoma, stage IV grade 1 follicular lymphoma, stage IV grade 2 follicular lymphoma

Brief summary

RATIONALE: Studying the effects of rituximab in blood and tumor tissue samples from patients with cancer in the laboratory may help doctors learn more about the effects of rituximab on cancer cells. It may also help doctors identify biomarkers related to cancer. PURPOSE: This research study is studying biomarkers in samples from patients with follicular lymphoma treated with rituximab.

Detailed description

OBJECTIVES: * Correlate immunoglobulin Fc receptor (FcγR) polymorphisms with response, response duration, and time to resistance in samples from patients with follicular lymphoma (FL) treated with single-agent rituximab on ECOG-E4402. * Identify gene expression profiles that correlate with response, response duration, and time to rituximab resistance in these patients. * Determine whether the FL microenvironment is predictive of initial response and duration of response to rituximab. OUTLINE: DNA and RNA from banked peripheral blood mononuclear cells (PBMCs) and formalin-fixed paraffin-embedded (FFPE) tumor samples are analyzed for immunoglobulin-receptor polymorphism, gene expression profile, and follicular lymphoma microenvironment by real-time PCR, microarray hybridization, and IHC. PROJECTED ACCRUAL: A total of 259 PBMC samples and 300 FFPE blocks will be accrued for this study.

Interventions

OTHERimmunohistochemistry staining method

OTHERlaboratory biomarker analysis

GENETICgene expression analysis

GENETICmicroarray analysis

GENETICpolymerase chain reaction

GENETICpolymorphism analysis

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 follicular lymphoma * Treated on ECOG-E4402 comprising 1 of 2 different rituximab-dose strategies * Banked peripheral blood mononuclear cells (PBMCs) and formalin-fixed paraffin-embedded (FFPE) tumor samples available PATIENT CHARACTERISTICS: * Not specified PRIOR CONCURRENT THERAPY: * See Disease Characteristics

Design outcomes

Primary

Measure	Time frame
Correlation between FcγR polymorphisms and rituximab response, response duration, and time to resistance	1 month

Outcome results

None listed

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