Biomarkers in DNA Samples From Patients With Chronic Lymphocytic Leukemia Previously Treated With Fludarabine-Based Therapy
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|ClinicalTrials.gov Identifier: NCT01145469|
Recruitment Status : Completed
First Posted : June 16, 2010
Last Update Posted : May 17, 2017
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|
- 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|
|Actual Enrollment :||225 participants|
|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|
- Association of single SNP genotype with overall and progression-free survival [ Time Frame: 1 month ]
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
|Principal Investigator:||Tait D. Shanafelt, MD||Mayo Clinic|