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DNA Analysis in Influencing Response to Rituximab in Samples From Patients With Follicular Lymphoma Treated on ECOG-E4402

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ClinicalTrials.gov Identifier: NCT01406782
Recruitment Status : Completed
First Posted : August 1, 2011
Last Update Posted : May 17, 2017
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group

Brief Summary:

RATIONALE: Studying samples of blood 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 DNA isolated from blood samples to see how well it influences response to rituximab in patients with follicular lymphoma treated on clinical trial ECOG-E4402.

Condition or disease Intervention/treatment
Lymphoma Biological: rituximab Genetic: DNA analysis Genetic: gene expression analysis Genetic: polymerase chain reaction Other: laboratory biomarker analysis

Detailed Description:


  • To test the influence of killer immunoglobulin-like receptor (KIR) and human lymphocyte antigen (HLA) genotype on response to anti-CD20 antibody lymphoma immunotherapy.

OUTLINE: DNA samples are analyzed for killer immunoglobulin-like receptor (KIR) and human lymphocyte antigen (HLA) genotyping with sequence-specific primers (SSP) by real-time PCR. KIR and HLA typing are analyzed according to KIR-HLA matched vs mismatched, KIR B haplotype content, and the number of inhibitory KIR-HLA pairs. Results are then correlated to each patient's overall response and duration of response to rituximab.

Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: The Influence of KIR and HLA Genotype on the Response to Rituximab Immunotherapy in Patients With Follicular Lymphoma
Actual Study Start Date : December 13, 2011
Primary Completion Date : January 13, 2012
Study Completion Date : January 13, 2012

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. KIR-HLA genotype predictive of antibody-dependent cell-mediated cytotoxicity (ADCC)-based cancer immunotherapy [ Time Frame: 1 year ]

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


  • Patients diagnosed with follicular lymphoma enrolled on ECOG-E4402

    • Treated with single-agent rituximab; the trial compared two different rituximab-dosing strategies - maintenance vs retreatment as needed
  • Available germline DNA samples isolated from peripheral blood as well as clinical evaluation of disease status prior to and at initial response to the therapy


  • Not specified


  • 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): NCT01406782

Sponsors and Collaborators
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Erik Ranheim, MD, PhD University of Wisconsin, Madison

Responsible Party: Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT01406782     History of Changes
Other Study ID Numbers: CDR0000706811
First Posted: August 1, 2011    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, Follicular
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents