NCT01406782

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2011

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 1, 2011

Completed
4 months until next milestone

Study Start

First participant enrolled

December 13, 2011

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 13, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 13, 2012

Completed
Last Updated

May 17, 2017

Status Verified

May 1, 2017

Enrollment Period

1 month

First QC Date

July 29, 2011

Last Update Submit

May 16, 2017

Conditions

Keywords

stage III grade 1 follicular lymphomastage III grade 2 follicular lymphomastage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphoma

Outcome Measures

Primary Outcomes (1)

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

    1 year

Interventions

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

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

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

Sponsors & Collaborators

MeSH Terms

Conditions

LymphomaLymphoma, Follicular

Interventions

RituximabGene Expression ProfilingPolymerase Chain Reaction

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, Non-Hodgkin

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsGenetic TechniquesInvestigative TechniquesNucleic Acid Amplification Techniques

Study Officials

  • Erik Ranheim, MD, PhD

    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

July 29, 2011

First Posted

August 1, 2011

Study Start

December 13, 2011

Primary Completion

January 13, 2012

Study Completion

January 13, 2012

Last Updated

May 17, 2017

Record last verified: 2017-05