Trials / Completed
CompletedNCT01145469
Biomarkers in DNA Samples From Patients With Chronic Lymphocytic Leukemia Previously Treated With Fludarabine-Based Therapy
Genome Wide Association Study Evaluating Genetic Factors Related to the Efficacy and Tolerability of Fludarabine Treatment in Patients With CLL
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 225 (actual)
- Sponsor
- Eastern Cooperative Oncology Group · Network
- Sex
- All
- Age
- 18 Years – 120 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| GENETIC | DNA analysis | |
| GENETIC | gene expression analysis | |
| GENETIC | polymorphism analysis | |
| OTHER | laboratory biomarker analysis | |
| OTHER | medical chart review |
Timeline
- Start date
- 2010-06-01
- Primary completion
- 2010-08-01
- Completion
- 2010-08-01
- First posted
- 2010-06-16
- Last updated
- 2017-05-17
Source: ClinicalTrials.gov record NCT01145469. Inclusion in this directory is not an endorsement.