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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01406782
First Posted: August 1, 2011
Last Update Posted: May 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group
  Purpose

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 Intervention
Lymphoma Biological: rituximab Genetic: DNA analysis Genetic: gene expression analysis Genetic: polymerase chain reaction Other: laboratory biomarker analysis

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Eastern Cooperative Oncology Group:

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

Enrollment: 200
Actual Study Start Date: December 13, 2011
Study Completion Date: January 13, 2012
Primary Completion Date: January 13, 2012 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • 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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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:

  • 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

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  Contacts and Locations
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)
Investigators
Principal Investigator: Erik Ranheim, MD, PhD University of Wisconsin, Madison
  More Information

Responsible Party: Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT01406782     History of Changes
Other Study ID Numbers: CDR0000706811
ECOG-E4402T3
First Submitted: July 29, 2011
First Posted: August 1, 2011
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


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