Skip to main content
OpenTrials
Completed

NCT Number: NCT01150643

Biomarkers in Samples From Patients With Follicular Lymphoma Treated With Rituximab

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

gene expression analysis

Genetic

microarray analysis

Genetic

polymerase chain reaction

Genetic

polymorphism analysis

Genetic

immunohistochemistry staining method

Other

laboratory biomarker analysis

Other

Primary outcomes

  1. Correlation between FcγR polymorphisms and rituximab response, response duration, and time to resistance

    Time frame: 1 month

Sponsors and collaborators

Lead sponsor

Eastern Cooperative Oncology Group

Network

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Identification of Biomarkers Predicting Responsiveness to Rituximab in Follicular Lymphoma

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jun 25, 2010
Registry last updated
May 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.