Biomarkers in Predicting Response to Rituximab Treatment in Samples From Patients With Indolent Follicular Lymphoma

Lymphoma Clinical Trial

Official title:

Validating the Predictive Value (of Response to Rituximab Induction and Maintenance) of the FCGR3A 158V/F Polymorphism Using Complimentary Genotyping Methods

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01381705
• Other study ID #: CDR0000701978
• Secondary ID: ECOG-E4402T2
• Status: Completed
• Phase: N/A
• First received: June 23, 2011
• Last updated: May 16, 2017
• Start date: February 6, 2012
• Est. completion date: July 6, 2012

Study information

• Verified date: May 2017
• Source: Eastern Cooperative Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

RATIONALE: Studying samples of blood and tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how well patients will respond to treatment.

PURPOSE: This research study is studying biomarkers in predicting response to rituximab treatment in samples from patients with indolent follicular lymphoma.

Description:

OBJECTIVES:

Primary

• Genotype the full cohort of samples available from the RESORT clinical trial (ECOG-E4402) for FCGR3A 158V/F in parallel to independently verify results.

• Correlate the FCGR3A 158V/F polymorphisms to response, response duration, and time to rituximab resistance.

Secondary

• Quantify copy number variation in FCGR3A in this cohort.

OUTLINE: Archived DNA samples isolate from peripheral blood mononuclear cells and from formalin-fixed paraffin-embedded tissue samples are analyzed for FCGR3A 158V/F polymorphisms using different complementary genotyping methods. Assay results are reviewed and compared with patients' outcome data.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 259
• Est. completion date: July 6, 2012
• Est. primary completion date: July 6, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

DISEASE CHARACTERISTICS:

• Diagnosed with indolent follicular lymphoma

• Treated on RESORT trial (ECOG-E4402) comprising rituximab monotherapy and then randomized to rituximab maintenance therapy or retreatment with rituximab upon disease relapse

• Blood and tissue samples from patients available

PATIENT CHARACTERISTICS:

• Not specified

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Follicular

Intervention

Biological:
• rituximab

Genetic:
• DNA analysis

• gene expression analysis

• polymorphism analysis

Other:
• laboratory biomarker analysis

• medical chart review

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
ECOG-ACRIN Cancer Research Group	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation of FCGR3A 158V/F polymorphisms with response, duration of response, and time to rituximab resistance		1 year
Secondary	Copy number variation in FCGR3A cohort		1 year