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

E

Eastern Cooperative Oncology Group

Status

Completed

Conditions

Leukemia

Treatments

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

Study type

Observational

Funder types

NETWORK
NIH

Identifiers

NCT01145469
CDR0000674957
ECOG-E2997T2

Details and patient eligibility

About

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.

Full 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.

Enrollment

225 patients

Sex

All

Ages

18 to 120 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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