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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.
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.
Age
All ages
Sex
ALL
Healthy Volunteers
No
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
Start Date
October 1, 2009
Primary Completion Date
April 1, 2022
Completion Date
April 1, 2022
Last Updated
August 3, 2022
600
ESTIMATED participants
fluorescence in situ hybridization
GENETIC
mutation analysis
GENETIC
nucleic acid sequencing
GENETIC
polymerase chain reaction
GENETIC
western blotting
GENETIC
flow cytometry
OTHER
laboratory biomarker analysis
OTHER
Lead Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
NCT06285890
NCT06311227
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07388563