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

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ClinicalTrials.gov Identifier: NCT01057459
Recruitment Status : Completed
First Posted : January 27, 2010
Last Update Posted : June 27, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Tracking Information
First Submitted Date January 26, 2010
First Posted Date January 27, 2010
Last Update Posted Date June 27, 2017
Actual Study Start Date February 2010
Actual Primary Completion Date June 23, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 23, 2015)
overall response [ Time Frame: Baseline ]
Original Primary Outcome Measures
 (submitted: January 26, 2010)
Association between killer immunoglobulin-like receptor (KIR) and HLA genotypes and 12-month overall response
Change History Complete list of historical versions of study NCT01057459 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: July 23, 2015)
  • Progression-free survival [ Time Frame: Baseline ]
  • Overall survival [ Time Frame: Baseline ]
Original Secondary Outcome Measures
 (submitted: January 26, 2010)
Association between KIR and HLA genotypes and survival outcomes
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title DNA Analysis in Predicting Response to Antibody Therapy in Patients With Follicular Lymphoma Treated on Clinical Trials CALGB-50402 or CALGB-50701
Official Title Natural Killer Cell KIR and HLA Genotypes May Predict Response to Antibody Therapy in Follicular Lymphoma
Brief Summary 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

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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood
Sampling Method Probability Sample
Study Population Patients diagnosed with follicular lymphoma treated on CALGB 50402 or 50701 protocols
Condition Lymphoma
Intervention Other: laboratory biomarker analysis
Correlative studies
Study Groups/Cohorts Ancillary-Correlative (biomarkers and treatment outcomes)
Genomic DNA is extracted from previously collected blood samples for KIR and HLA genotyping and polymorphism analysis.
Intervention: Other: laboratory biomarker analysis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 26, 2017)
78
Original Estimated Enrollment
 (submitted: January 26, 2010)
106
Actual Study Completion Date June 23, 2014
Actual Primary Completion Date June 23, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01057459
Other Study ID Numbers CALGB-150905
CDR0000664103
NCI-2011-02204 ( Registry Identifier: NCI Physician Data Query )
U10CA180821 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Alliance for Clinical Trials in Oncology
Study Sponsor Alliance for Clinical Trials in Oncology
Collaborators National Cancer Institute (NCI)
Investigators
Study Chair: Jeffrey Venstrom, MD Memorial Sloan Kettering Cancer Center
PRS Account Alliance for Clinical Trials in Oncology
Verification Date June 2017