- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01005368
Study of Biomarkers in Blood and Bone Marrow Samples From Patients With Previously Untreated Chronic Lymphocytic Leukemia
Molecular Markers Of Chronic Lymphocytic Leukemia
RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.
PURPOSE: This research study is looking at biomarkers in blood and bone marrow samples from patients with previously untreated chronic lymphocytic leukemia.
Study Overview
Status
Conditions
Detailed Description
OBJECTIVES:
- Determine the relevance of common and uncommon interphase cytogenetic abnormalities related to baseline clinical features, complete response (CR), prolonged progression-free survival (PFS), and overall survival (OS) in patients with previously untreated chronic lymphocytic leukemia.
- Determine the significance of the absence of IgV_H gene mutational status as related to the ability to predict CR, PFS, and OS in these patients.
- Correlate IgV_H gene mutational status with CD38 expression, ZAP-70 expression, over-expression of Mcl-1, BAK-1, high Mcl-1:Bax ratio, p53 mutations or dysfunction, high-risk karyotype abnormalities, and other molecular features associated with poor outcome in these patients.
- Determine the prognostic significance of over-expression of Mcl-1, BAK-1, high Mcl-1:Bax ratio, p53 mutations or dysfunction, ATM mutation, ATM expression, and other factors that disrupt apoptosis with respect to CR, prolonged PFS, and OS.
- Determine if clonal evolution occurs in these biological markers at partial response or disease relapse.
OUTLINE: This is a multicenter study.
Blood and bone marrow is collected at baseline, 3 months after completion of induction therapy, 2 months after completion of consolidation therapy, 1 year after completion of study treatment, and at disease relapse. Samples are analyzed by FISH for interphase cytogenetics, PCR for IgV_H mutational status, flow cytometry for surface expression of CD38 cells, western blot to assess Mcl-1, Bcl-2, BAK-1, ATM, ZAP-70, and Bar expression, and sequencing for p53 and ATM function.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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California
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San Diego, California, United States, 92108
- Kaiser Permanente Medical Office -Vandever Medical Office
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Delaware
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Lewes, Delaware, United States, 19958
- Tunnell Cancer Center at Beebe Medical Center
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Newark, Delaware, United States, 19713
- CCOP - Christiana Care Health Services
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District of Columbia
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Washington, District of Columbia, United States, 20007
- Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
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Illinois
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Chicago, Illinois, United States, 60637-1470
- University of Chicago Cancer Research Center
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Chicago, Illinois, United States, 60640
- Louis A. Weiss Memorial Hospital
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Indiana
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Fort Wayne, Indiana, United States, 46845
- Fort Wayne Medical Oncology and Hematology
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Iowa
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Iowa City, Iowa, United States, 52242-1002
- Holden Comprehensive Cancer Center at University of Iowa
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Maine
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Augusta, Maine, United States, 04330
- Harold Alfond Center for Cancer Care
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Bangor, Maine, United States, 04401
- CancerCare of Maine at Eastern Maine Medical Center
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Maryland
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Bethesda, Maryland, United States, 20889-5600
- National Naval Medical Center
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Elkton, Maryland, United States, 21921
- Union Hospital of Cecil County
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Minnesota
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Minneapolis, Minnesota, United States, 55417
- Veterans Affairs Medical Center - Minneapolis
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Missouri
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Cape Girardeau, Missouri, United States, 63703
- Southeast Cancer Center
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Columbia, Missouri, United States, 65203
- Ellis Fischel Cancer Center at University of Missouri - Columbia
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Jefferson City, Missouri, United States, 65109
- Goldschmidt Cancer Center
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Saint Louis, Missouri, United States, 63131
- Missouri Baptist Cancer Center
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Saint Louis, Missouri, United States, 63110
- Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
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Nebraska
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Grand Island, Nebraska, United States, 68803
- Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center
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North Platte, Nebraska, United States, 69103
- Callahan Cancer Center at Great Plains Regional Medical Center
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Omaha, Nebraska, United States, 68198-6805
- UNMC Eppley Cancer Center at the University of Nebraska Medical Center
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New Jersey
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Voorhees, New Jersey, United States, 08043
- Cancer Institute of New Jersey at Cooper - Voorhees
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New York
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East Syracuse, New York, United States, 13057
- CCOP - Hematology-Oncology Associates of Central New York
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New York, New York, United States, 10021
- New York Weill Cornell Cancer Center at Cornell University
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Syracuse, New York, United States, 13210
- SUNY Upstate Medical University Hospital
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North Carolina
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Charlotte, North Carolina, United States, 28233-3549
- Presbyterian Cancer Center at Presbyterian Hospital
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Goldsboro, North Carolina, United States, 27534
- Wayne Memorial Hospital, Incorporated
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Hendersonville, North Carolina, United States, 28791
- Pardee Memorial Hospital
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Kinston, North Carolina, United States, 28501
- Kinston Medical Specialists
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Winston-Salem, North Carolina, United States, 27157-1096
- Wake Forest University Comprehensive Cancer Center
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Ohio
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Columbus, Ohio, United States, 43210-1240
- Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15224-1791
- Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
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South Carolina
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Florence, South Carolina, United States, 29501
- McLeod Regional Medical Center
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Vermont
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Berlin, Vermont, United States, 05602
- Mountainview Medical
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Burlington, Vermont, United States, 05401
- Fletcher Allen Health Care - University Health Center Campus
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
DISEASE CHARACTERISTICS:
Diagnosis of chronic lymphocytic leukemia
- Previously untreated disease
- Registered to receive treatment on a Cancer and Leukemia Group B protocol
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Group 1
Blood and bone marrow is collected at baseline, 3 months after completion of induction therapy, 2 months after completion of consolidation therapy, 1 year after completion of study treatment, and at disease relapse.
Samples are analyzed by FISH for interphase cytogenetics, PCR for IgV_H mutational status, flow cytometry for surface expression of CD38 cells, western blot to assess Mcl-1, Bcl-2, BAK-1, ATM, ZAP-70, and Bar expression, and sequencing for p53 and ATM function.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
overall survival
Time Frame: Up to 10 years
|
Up to 10 years
|
complete response
Time Frame: Up to 10 years
|
Up to 10 years
|
prolonged progression-free survival
Time Frame: Up to 10 years
|
Up to 10 years
|
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: John C. Byrd, MD, Ohio State University Comprehensive Cancer Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CALGB-20203
- CDR0000398201 (Registry Identifier: NCI Physician Data Query)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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