Study of Blood and Bone Marrow Samples in Patients With Chronic Myelogenous Leukemia Enrolled on a CALGB Clinical Trial
Recruitment status was Active, not recruiting
RATIONALE: Studying samples of blood and bone marrow from patients with cancer may help doctors identify biomarkers related to cancer.
PURPOSE: This research study is looking at blood and bone marrow samples in patients with chronic myelogenous leukemia enrolled on a CALGB clinical trial.
Genetic: DNA analysis
Genetic: Southern blotting
Genetic: cytogenetic analysis
Genetic: polymerase chain reaction
|Official Title:||Molecular and Cytogenetic Monitoring of CML - A Mandatory Companion to CALGB 19804|
- Distribution response as determined by both quantitative RT-PCR and Southern blot monitoring of blood samples periodically during treatment and then at 6-12 month intervals [ Designated as safety issue: No ]
- Distribution of cytogenetic response among complete RT-PCR responders or complete Southern blot responders [ Designated as safety issue: No ]
- Distribution of RT-PCR response or Southern blot response among complete cytogenetic responders [ Designated as safety issue: No ]
- Frequency of residual disease in patients who have achieved a complete response using blood Southern blot and marrow cytogenetics at courses 3 and 9 and at 12-month follow up [ Designated as safety issue: No ]
- Monitor molecular response rates of patients receiving treatment for chronic myelogenous leukemia by quantitative reverse transcription polymerase chain reaction (RT-PCR) and quantitative Southern blot monitoring of blood samples.
- Compare quantitative RT-PCR and quantitative Southern blot results with marrow cytogenetics at the time of complete molecular response in these patients.
- Monitor the frequency of residual disease in patients who achieve a complete blood Southern blot and marrow cytogenetic response (eradication of BCR/ABL by Southern blot and absence of the Philadelphia chromosome by cytogenetics).
OUTLINE: Peripheral blood samples and bone marrow aspirates are collected at baseline and at 3, 6, and 9 months after starting therapy. If patient continues to receive protocol treatment after 9 months, additional peripheral blood samples are collected every 6 months and bone marrow aspirates are taken annually. In the event of disease progression (blast crisis), an additional peripheral blood sample and bone marrow aspirate are collected.
Samples are examined by quantitative Southern blot analysis with probes to BCR, quantitative reverse transcriptase-polymerase chain reaction analysis for BCR/ABL fusion transcripts, and cytogenetic analysis.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 1.5 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01004640
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|Study Chair:||Wendy Stock, MD||University of Chicago|