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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. Identifier: NCT01145469
Recruitment Status : Completed
First Posted : June 16, 2010
Last Update Posted : May 17, 2017
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group

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.

Condition or disease Intervention/treatment
Leukemia Genetic: DNA analysis Genetic: gene expression analysis Genetic: polymorphism analysis Other: laboratory biomarker analysis Other: medical chart review

Detailed Description:


  • 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.

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Study Type : Observational
Actual Enrollment : 225 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Genome Wide Association Study Evaluating Genetic Factors Related to the Efficacy and Tolerability of Fludarabine Treatment in Patients With CLL
Actual Study Start Date : June 1, 2010
Actual Primary Completion Date : August 1, 2010
Actual Study Completion Date : August 1, 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia

Primary Outcome Measures :
  1. Association of single SNP genotype with overall and progression-free survival [ Time Frame: 1 month ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Samples from patients enrolled on E4402 from whom samples were submitted for research


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


  • Not specified


  • See Disease Characteristics

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01145469

Sponsors and Collaborators
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
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Principal Investigator: Tait D. Shanafelt, MD Mayo Clinic
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Responsible Party: Eastern Cooperative Oncology Group Identifier: NCT01145469    
Other Study ID Numbers: CDR0000674957
First Posted: June 16, 2010    Key Record Dates
Last Update Posted: May 17, 2017
Last Verified: May 2017
Keywords provided by Eastern Cooperative Oncology Group:
stage I chronic lymphocytic leukemia
stage II chronic lymphocytic leukemia
stage III chronic lymphocytic leukemia
stage IV chronic lymphocytic leukemia
B-cell chronic lymphocytic leukemia
Additional relevant MeSH terms:
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Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Leukemia, Lymphoid
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell