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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01145469
First Posted: June 16, 2010
Last Update Posted: May 17, 2017
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.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group
  Purpose

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 Intervention
Leukemia Genetic: DNA analysis Genetic: gene expression analysis Genetic: polymorphism analysis Other: laboratory biomarker analysis Other: medical chart review

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Eastern Cooperative Oncology Group:

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

Enrollment: 225
Actual Study Start Date: June 1, 2010
Study Completion Date: August 1, 2010
Primary Completion Date: August 1, 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
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
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01145469


Sponsors and Collaborators
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Tait D. Shanafelt, MD Mayo Clinic
  More Information

Responsible Party: Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT01145469     History of Changes
Other Study ID Numbers: CDR0000674957
ECOG-E2997T2
First Submitted: June 15, 2010
First Posted: June 16, 2010
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:
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Fludarabine
Fludarabine phosphate
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs