Biomarkers in Samples From Patients With Follicular Lymphoma Treated With Rituximab

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by National Cancer Institute (NCI).
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01150643
First received: June 24, 2010
Last updated: June 29, 2010
Last verified: June 2010

June 24, 2010
June 29, 2010
August 2010
September 2010   (final data collection date for primary outcome measure)
  • Correlation between FcγR polymorphisms and rituximab response, response duration, and time to resistance [ Designated as safety issue: No ]
  • Identification of gene expression profiles correlated with rituximab response, response duration, and time to resistance [ Designated as safety issue: No ]
  • Follicular lymphoma microenvironment predictive of rituximab initial response and duration of response [ Designated as safety issue: No ]
Same as current
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
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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.
 
Not yet recruiting
559
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September 2010   (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
Both
18 Years and older
No
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NCT01150643
CDR0000675681, ECOG-E4402T1
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Robert L. Comis, ECOG Group Chair's Office
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Brad S. Kahl, MD University of Wisconsin, Madison
National Cancer Institute (NCI)
June 2010

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