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Completed

NCT Number: NCT01057459

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

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.

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Key information

Conditions

Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Memorial Sloan-Kettering Cancer Center

New York, 10065, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

laboratory biomarker analysis

Other

Correlative studies

Primary outcomes

  1. overall response

    Time frame: Baseline

Secondary outcomes

  1. Progression-free survival

    Time frame: Baseline

  2. Overall survival

    Time frame: Baseline

Sponsors and collaborators

Lead sponsor

Alliance for Clinical Trials in Oncology

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Natural Killer Cell KIR and HLA Genotypes May Predict Response to Antibody Therapy in Follicular Lymphoma

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Jan 27, 2010
Registry last updated
Jun 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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