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

NCT01381705 | Completed

• 2 other identifiers: CDR0000701978ECOG-E4402T2
• Study Type: observational
• Target: 259
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Lymphoma

Keywords

recurrent grade 1 follicular lymphoma; recurrent grade 2 follicular lymphoma

Outcome Measures

Primary Outcomes (1)

• Correlation of FCGR3A 158V/F polymorphisms with response, duration of response, and time to rituximab resistance

  1 year

Secondary Outcomes (1)

• Copy number variation in FCGR3A cohort

  1 year

Interventions

rituximab BIOLOGICAL

DNA analysis GENETIC

gene expression analysis GENETIC

polymorphism analysis GENETIC

laboratory biomarker analysis OTHER

medical chart review OTHER

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Samples from patients enrolled in E4402 from whom samples were submitted for research

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• ECOG-ACRIN Cancer Research Group: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Lymphoma; Lymphoma, Follicular

Interventions

Rituximab; Gene Expression Profiling; Amplified Fragment Length Polymorphism Analysis

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, Non-Hodgkin

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Genetic Techniques; Investigative Techniques; DNA Fingerprinting; Polymerase Chain Reaction; Nucleic Acid Amplification Techniques

Study Officials

• Brad S. Kahl, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2011
• First Posted: June 27, 2011
• Study Start: February 6, 2012
• Primary Completion: July 6, 2012
• Study Completion: July 6, 2012
• Last Updated: May 17, 2017

Record last verified: 2017-05