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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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01057459
First received: January 26, 2010
Last updated: April 24, 2010
Last verified: February 2010
History of Changes
  Purpose

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 looking at DNA in blood samples to see how well it predicts response to antibody therapy in patients with follicular lymphoma treated on clinical trials CALGB-50402 or CALGB-50701.


Condition Intervention
Lymphoma
 Biological: rituximab
Genetic: gene expression analysis
Genetic: polymorphism analysis
Other: laboratory biomarker analysis

Study Type: Observational
Official Title: Natural Killer Cell KIR and HLA Genotypes May Predict Response to Antibody Therapy in Follicular Lymphoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lymphoma
Drug Information available for: Rituximab
U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Association between killer immunoglobulin-like receptor (KIR) and HLA genotypes and 12-month overall response [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Association between KIR and HLA genotypes and survival outcomes [ Designated as safety issue: No ]

Estimated Enrollment: 106
Study Start Date: February 2010
Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • To test the hypothesis that killer immunoglobulin-like receptor (KIR) and HLA genotypes predict 12-month overall response (complete response, partial response, and unconfirmed complete response) in patients with follicular lymphoma treated with rituximab-containing monoclonal antibody combinations on CALGB-50402 or CALGB-50701.

Secondary

  • To test the hypothesis that KIR and HLA genotypes are associated with survival outcomes (progression-free and overall survival) in these patients.

OUTLINE: This is a multicenter study.

Genomic DNA is extracted from previously collected whole blood samples for killer immunoglobulin-like receptor (KIR) and HLA genotyping and polymorphism analysis.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of follicular lymphoma
  • Has received rituximab-containing monoclonal antibody therapy on CALGB-50402 or CALGB-50701

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01057459

Sponsors and Collaborators
Cancer and Leukemia Group B
National Cancer Institute (NCI)
Investigators
Principal Investigator: Jeffrey M. Venstrom, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Monica M. Bertagnolli, Cancer and Leukemia Group B
ClinicalTrials.gov Identifier: NCT01057459     History of Changes
Other Study ID Numbers: CDR0000664103, CALGB-150905
Study First Received: January 26, 2010
Last Updated: April 24, 2010
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
contiguous stage II grade 1 follicular lymphoma
contiguous stage II grade 2 follicular lymphoma
contiguous stage II grade 3 follicular lymphoma
noncontiguous stage II grade 1 follicular lymphoma
noncontiguous stage II grade 2 follicular lymphoma
noncontiguous stage II grade 3 follicular lymphoma
 stage III grade 1 follicular lymphoma
stage III grade 2 follicular lymphoma
stage III grade 3 follicular lymphoma
stage IV grade 1 follicular lymphoma
stage IV grade 2 follicular lymphoma
stage IV grade 3 follicular lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Follicular
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
 Lymphoma, Non-Hodgkin
Rituximab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on June 17, 2013