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Study of Biomarkers in Blood and Bone Marrow Samples From Patients With Previously Untreated Chronic Lymphocytic Leukemia

Disease Information

Descriptive Information
Brief Title † Study of Biomarkers in Blood and Bone Marrow Samples From Patients With Previously Untreated Chronic Lymphocytic Leukemia
Official Title † Molecular Markers Of Chronic Lymphocytic Leukemia
Brief Summary 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.
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 Phase N/A
Study Type † Observational
Study Design † Observational Model: Case-Only, Time Perspective: Retrospective
Primary Outcome Measure † complete response
Secondary Outcome Measure †
Condition † Leukemia
Intervention † Geneticfluorescence in situ hybridization
Study Arms / Comparison Groups 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.
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Genetic
Estimated Enrollment † 600
Start Date † October 2009
Completion Date
Primary Completion Date January 2100
Eligibility Criteria † 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
Gender Both
Ages N/A - N/A
Accepts Healthy Volunteers No
Contacts ††
Location Countries † United States
Administrative Information
NCT ID † NCT01005368
Organization ID CALGB-20203
Secondary IDs †† CALGB-20203, CDR0000398201
Responsible Party Sponsor
Study Sponsor † Alliance for Clinical Trials in Oncology
Collaborators †† National Cancer Institute (NCI)
Investigators † Study Chair: John C. Byrd, MD, Ohio State University Comprehensive Cancer Center
Information Provided By
Verification Date July 2015
First Received Date † October 29, 2009
Last Updated Date July 9, 2015
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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