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Biomarkers in Samples From Patients With Follicular Lymphoma Treated With Rituximab

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier:
NCT01150643
First received: June 24, 2010
Last updated: May 16, 2017
Last verified: May 2017

June 24, 2010
May 16, 2017
December 6, 2010
January 6, 2011   (Final data collection date for primary outcome measure)
Correlation between FcγR polymorphisms and rituximab response, response duration, and time to resistance [ Time Frame: 1 month ]
  • Correlation between FcγR polymorphisms and rituximab response, response duration, and time to resistance
  • Identification of gene expression profiles correlated with rituximab response, response duration, and time to resistance
  • Follicular lymphoma microenvironment predictive of rituximab initial response and duration of response
Complete list of historical versions of study NCT01150643 on ClinicalTrials.gov Archive Site
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Biomarkers in Samples From Patients With Follicular Lymphoma Treated With Rituximab
Identification of Biomarkers Predicting Responsiveness to Rituximab in Follicular Lymphoma

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.

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.

Observational
Observational Model: Other
Time Perspective: Retrospective
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Non-Probability Sample
Samples from patients enrolled on E4402 from whom samples were submitted for research
Lymphoma
  • Genetic: gene expression analysis
  • Genetic: microarray analysis
  • Genetic: polymerase chain reaction
  • Genetic: polymorphism analysis
  • Other: immunohistochemistry staining method
  • Other: laboratory biomarker analysis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
559
January 6, 2011
January 6, 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 120 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
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NCT01150643
CDR0000675681
ECOG-E4402T1
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Eastern Cooperative Oncology Group
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Brad S. Kahl, MD University of Wisconsin, Madison
Eastern Cooperative Oncology Group
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP