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Biomarkers in Samples From Patients With Follicular Lymphoma Treated With Rituximab

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ClinicalTrials.gov Identifier: NCT01150643
Recruitment Status : Completed
First Posted : June 25, 2010
Last Update Posted : May 17, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group

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.


Condition or disease Intervention/treatment
Lymphoma Genetic: gene expression analysis Genetic: microarray analysis Genetic: polymerase chain reaction Genetic: polymorphism analysis Other: immunohistochemistry staining method Other: laboratory biomarker analysis

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.


Study Type : Observational
Actual Enrollment : 559 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Identification of Biomarkers Predicting Responsiveness to Rituximab in Follicular Lymphoma
Actual Study Start Date : December 6, 2010
Actual Primary Completion Date : January 6, 2011
Actual Study Completion Date : January 6, 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab
U.S. FDA Resources




Primary Outcome Measures :
  1. Correlation between FcγR polymorphisms and rituximab response, response duration, and time to resistance [ Time Frame: 1 month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Samples from patients enrolled on E4402 from whom samples were submitted for research
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01150643


Sponsors and Collaborators
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Brad S. Kahl, MD University of Wisconsin, Madison

Responsible Party: Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT01150643     History of Changes
Other Study ID Numbers: CDR0000675681
ECOG-E4402T1
First Posted: June 25, 2010    Key Record Dates
Last Update Posted: May 17, 2017
Last Verified: May 2017

Keywords provided by Eastern Cooperative Oncology Group:
stage III grade 1 follicular lymphoma
stage III grade 2 follicular lymphoma
stage IV grade 1 follicular lymphoma
stage IV grade 2 follicular lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Follicular
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Rituximab
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents