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Biomarkers in DNA Samples From Patients With Chronic Lymphocytic Leukemia Previously Treated With Fludarabine-Based Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01145469
Recruitment Status : Completed
First Posted : June 16, 2010
Last Update Posted : May 17, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group

Tracking Information
First Submitted Date June 15, 2010
First Posted Date June 16, 2010
Last Update Posted Date May 17, 2017
Actual Study Start Date June 1, 2010
Actual Primary Completion Date August 1, 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 16, 2017)
Association of single SNP genotype with overall and progression-free survival [ Time Frame: 1 month ]
Original Primary Outcome Measures
 (submitted: June 15, 2010)
  • Association of single SNP genotype with overall and progression-free survival
  • Candidate genes associated with the efficacy and toxicity of fludarabine-based treatment
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Biomarkers in DNA Samples From Patients With Chronic Lymphocytic Leukemia Previously Treated With Fludarabine-Based Therapy
Official Title Genome Wide Association Study Evaluating Genetic Factors Related to the Efficacy and Tolerability of Fludarabine Treatment in Patients With CLL
Brief Summary

RATIONALE: Studying samples of DNA in the laboratory from patients who received fludarabine-based treatment may help doctors learn more about the effects of fludarabine on cells. It may also help doctors understand how well patients respond to treatment.

PURPOSE: This research study is studying DNA samples from patients with chronic lymphocytic leukemia previously treated with fludarabine-based therapy.

Detailed Description

OBJECTIVES:

  • To identify genetic characteristics associated with the efficacy and toxicity of fludarabine-based treatment in patients with chronic lymphocytic leukemia who participated on E2997.
  • To validate these genetic characteristics with a cancer cell model system to confirm association and dissect the mechanism of effect.

OUTLINE: Archived DNA samples are analyzed for genetic characteristics associated with the efficacy and toxicity to fludarabine-based treatment using Affymetrix 6.0 single nucleotide polymorphism arrays. The results are then compared with data of genes identified in a cancer cell model system, and with clinical data (response, toxicity, overall survival, and progression-free survival) associated with each patient sample.

Study Type Observational
Study Design Observational Model: Other
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Samples from patients enrolled on E4402 from whom samples were submitted for research
Condition Leukemia
Intervention
  • Genetic: DNA analysis
  • Genetic: gene expression analysis
  • Genetic: polymorphism analysis
  • Other: laboratory biomarker analysis
  • Other: medical chart review
Study Groups/Cohorts Not Provided
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 15, 2010)
225
Original Estimated Enrollment Same as current
Actual Study Completion Date August 1, 2010
Actual Primary Completion Date August 1, 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of chronic lymphocytic leukemia
  • Archived DNA samples
  • Received fludarabine with versus without cyclophosphamide on clinical trial E2997

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 120 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT01145469
Other Study ID Numbers CDR0000674957
ECOG-E2997T2
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Eastern Cooperative Oncology Group
Study Sponsor Eastern Cooperative Oncology Group
Collaborators National Cancer Institute (NCI)
Investigators
Principal Investigator: Tait D. Shanafelt, MD Mayo Clinic
PRS Account Eastern Cooperative Oncology Group
Verification Date May 2017