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

NCT ID: NCT01381705

Last Updated: 2017-05-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 259 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-02-06
• Study Completion Date: 2012-07-06

Brief 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.

Detailed 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.

Conditions

Lymphoma

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Interventions

rituximab

Intervention Type: BIOLOGICAL

DNA analysis

Intervention Type: GENETIC

gene expression analysis

Intervention Type: GENETIC

polymorphism analysis

Intervention Type: GENETIC

laboratory biomarker analysis

Intervention Type: OTHER

medical chart review

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

ECOG-ACRIN Cancer Research Group

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brad S. Kahl, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Other Identifiers

ECOG-E4402T2

Identifier Type: -

Identifier Source: secondary_id

CDR0000701978

Identifier Type: -

Identifier Source: org_study_id