Study of Biomarkers in Blood and Bone Marrow Samples From Patients With Previously Untreated Chronic Lymphocytic Leukemia
NCT ID: NCT01005368
Last Updated: 2022-08-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
600 participants
OBSERVATIONAL
2009-10-31
2022-04-01
Brief Summary
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PURPOSE: This research study is looking at biomarkers in blood and bone marrow samples from patients with previously untreated chronic lymphocytic leukemia.
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Detailed Description
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* 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.
Conditions
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Study Design
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CASE_ONLY
RETROSPECTIVE
Study Groups
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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.
fluorescence in situ hybridization
mutation analysis
nucleic acid sequencing
polymerase chain reaction
western blotting
flow cytometry
laboratory biomarker analysis
Interventions
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fluorescence in situ hybridization
mutation analysis
nucleic acid sequencing
polymerase chain reaction
western blotting
flow cytometry
laboratory biomarker analysis
Eligibility Criteria
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Inclusion Criteria
* 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
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
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Principal Investigators
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John C. Byrd, MD
Role: STUDY_CHAIR
Ohio State University Comprehensive Cancer Center
Locations
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Kaiser Permanente Medical Office -Vandever Medical Office
San Diego, California, United States
Tunnell Cancer Center at Beebe Medical Center
Lewes, Delaware, United States
CCOP - Christiana Care Health Services
Newark, Delaware, United States
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
Washington D.C., District of Columbia, United States
University of Chicago Cancer Research Center
Chicago, Illinois, United States
Louis A. Weiss Memorial Hospital
Chicago, Illinois, United States
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, United States
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States
Harold Alfond Center for Cancer Care
Augusta, Maine, United States
CancerCare of Maine at Eastern Maine Medical Center
Bangor, Maine, United States
National Naval Medical Center
Bethesda, Maryland, United States
Union Hospital of Cecil County
Elkton, Maryland, United States
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, United States
Southeast Cancer Center
Cape Girardeau, Missouri, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, United States
Goldschmidt Cancer Center
Jefferson City, Missouri, United States
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
St Louis, Missouri, United States
Missouri Baptist Cancer Center
St Louis, Missouri, United States
Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center
Grand Island, Nebraska, United States
Callahan Cancer Center at Great Plains Regional Medical Center
North Platte, Nebraska, United States
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
Omaha, Nebraska, United States
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees Township, New Jersey, United States
CCOP - Hematology-Oncology Associates of Central New York
East Syracuse, New York, United States
New York Weill Cornell Cancer Center at Cornell University
New York, New York, United States
SUNY Upstate Medical University Hospital
Syracuse, New York, United States
Presbyterian Cancer Center at Presbyterian Hospital
Charlotte, North Carolina, United States
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, United States
Pardee Memorial Hospital
Hendersonville, North Carolina, United States
Kinston Medical Specialists
Kinston, North Carolina, United States
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States
McLeod Regional Medical Center
Florence, South Carolina, United States
Mountainview Medical
Berlin Corners, Vermont, United States
Fletcher Allen Health Care - University Health Center Campus
Burlington, Vermont, United States
Countries
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Other Identifiers
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CALGB-20203
Identifier Type: -
Identifier Source: secondary_id
CDR0000398201
Identifier Type: REGISTRY
Identifier Source: secondary_id
CALGB-20203
Identifier Type: -
Identifier Source: org_study_id
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