Biomarkers in DNA Samples From Patients With Chronic Lymphocytic Leukemia Previously Treated With Fludarabine-Based Therapy
|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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01145469
|Principal Investigator:||Tait D. Shanafelt, MD||Mayo Clinic|