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

NCT01406782 — Completed, 200 participants, Eastern Cooperative Oncology Group

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The Influence of KIR and HLA Genotype on the Response to Rituximab Immunotherapy in Patients With Follicular Lymphoma

RegistryNCT01406782
StatusCompleted
Study typeObservational
Enrollment200 (Actual)
SponsorEastern Cooperative Oncology Group (Network); collaborators: National Cancer Institute (NCI)
ConditionsLymphoma
Interventionsrituximab, DNA analysis, gene expression analysis, polymerase chain reaction, laboratory biomarker analysis (Biological, genetic, other)
Datesstart 2011-12-13, primary completion 2012-01-13, completion 2012-01-13, first posted 2011-08-01, last updated 2017-05-17

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-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.

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+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.

+Arms and interventions

  • rituximab (Biological)
  • DNA analysis (Genetic)
  • gene expression analysis (Genetic)
  • polymerase chain reaction (Genetic)
  • laboratory biomarker analysis (Other)

+Outcome measures

Primary outcomes

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

+Eligibility

Sex: All, ages: 18 Years to 120 Years

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

+Investigators

My Notes