DNA Analysis in Predicting Response to Antibody Therapy in Patients With Follicular Lymphoma Treated on Clinical Trials CALGB-50402 or CALGB-50701

NCT ID: NCT01057459

Last Updated: 2017-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

78 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-02-28

Study Completion Date

2014-06-23

Brief Summary

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This research trial studies deoxyribonucleic acid (DNA) analysis in predicting response to antibody therapy in patients with follicular lymphoma treated on clinical trials Cancer and Leukemia Group B (CALGB)-50402 or CALGB-50701. Studying samples of blood from patients with follicular lymphoma in the laboratory may help doctors predict how well patients will respond to treatment.

Detailed Description

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PRIMARY OBJECTIVES:

l. To test the hypothesis that killer immunoglobulin-like receptor (KIR) and human leukocyte antigen (HLA) genotypes predict overall response (partial response \[PR\], complete response\[CR\], and unconfirmed complete response \[CRu\]) within 12 months to rituximab-containing monoclonal antibody combinations in follicular lymphoma patients treated on CALGB protocols 50402 and 50701.

SECONDARY OBJECTIVES:

I. To test the hypothesis that KIR and HLA genotypes are associated with survival outcomes (progression-free survival \[PFS\] and overall survival \[OS\]) in follicular lymphoma patients treated with rituximab-containing monoclonal antibody combinations on CALGB protocols 50402 and 50701.

OUTLINE:

Genomic DNA is extracted from previously collected blood samples for KIR and HLA genotyping and polymorphism analysis.

Conditions

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Lymphoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Ancillary-Correlative (biomarkers and treatment outcomes)

Genomic DNA is extracted from previously collected blood samples for KIR and HLA genotyping and polymorphism analysis.

laboratory biomarker analysis

Intervention Type OTHER

Correlative studies

Interventions

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laboratory biomarker analysis

Correlative studies

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Untreated follicular lymphoma
* Has received rituximab-containing monoclonal antibody therapy on CALGB-50402 or CALGB-50701
* Patients have previously provided informed consent allowing correlative studies on genomic DNA
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Alliance for Clinical Trials in Oncology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jeffrey Venstrom, MD

Role: STUDY_CHAIR

Memorial Sloan Kettering Cancer Center

Locations

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Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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CDR0000664103

Identifier Type: -

Identifier Source: secondary_id

NCI-2011-02204

Identifier Type: REGISTRY

Identifier Source: secondary_id

U10CA180821

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CALGB-150905

Identifier Type: -

Identifier Source: org_study_id

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