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NCT01005368 Clinical Trial

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

Leukemia Clinical Trial

Official title:
Molecular Markers Of Chronic Lymphocytic Leukemia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01005368
Other study ID # CALGB-20203
Secondary ID CALGB-20203CDR00
Status Completed
Phase
First received
Last updated
Start date October 2009
Est. completion date April 1, 2022

Study information
Verified date August 2022
Source Alliance for Clinical Trials in Oncology
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 600
Est. completion date April 1, 2022
Est. primary completion date April 1, 2022
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Genetic:
• fluorescence in situ hybridization

• mutation analysis

• nucleic acid sequencing

• polymerase chain reaction

• western blotting

Other:
• flow cytometry

• laboratory biomarker analysis

Locations
Country Name City State
United States Harold Alfond Center for Cancer Care Augusta Maine
United States CancerCare of Maine at Eastern Maine Medical Center Bangor Maine
United States Mountainview Medical Berlin Vermont
United States National Naval Medical Center Bethesda Maryland
United States Fletcher Allen Health Care - University Health Center Campus Burlington Vermont
United States Southeast Cancer Center Cape Girardeau Missouri
United States Presbyterian Cancer Center at Presbyterian Hospital Charlotte North Carolina
United States Louis A. Weiss Memorial Hospital Chicago Illinois
United States University of Chicago Cancer Research Center Chicago Illinois
United States Ellis Fischel Cancer Center at University of Missouri - Columbia Columbia Missouri
United States Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center Columbus Ohio
United States CCOP - Hematology-Oncology Associates of Central New York East Syracuse New York
United States Union Hospital of Cecil County Elkton Maryland
United States McLeod Regional Medical Center Florence South Carolina
United States Fort Wayne Medical Oncology and Hematology Fort Wayne Indiana
United States Wayne Memorial Hospital, Incorporated Goldsboro North Carolina
United States Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center Grand Island Nebraska
United States Pardee Memorial Hospital Hendersonville North Carolina
United States Holden Comprehensive Cancer Center at University of Iowa Iowa City Iowa
United States Goldschmidt Cancer Center Jefferson City Missouri
United States Kinston Medical Specialists Kinston North Carolina
United States Tunnell Cancer Center at Beebe Medical Center Lewes Delaware
United States Veterans Affairs Medical Center - Minneapolis Minneapolis Minnesota
United States New York Weill Cornell Cancer Center at Cornell University New York New York
United States CCOP - Christiana Care Health Services Newark Delaware
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 Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital Pittsburgh Pennsylvania
United States Missouri Baptist Cancer Center Saint Louis Missouri
United States Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis Saint Louis Missouri
United States Kaiser Permanente Medical Office -Vandever Medical Office San Diego California
United States SUNY Upstate Medical University Hospital Syracuse New York
United States Cancer Institute of New Jersey at Cooper - Voorhees Voorhees New Jersey
United States Lombardi Comprehensive Cancer Center at Georgetown University Medical Center Washington District of Columbia
United States Wake Forest University Comprehensive Cancer Center Winston-Salem North Carolina

Sponsors (2)
Lead Sponsor Collaborator
Alliance for Clinical Trials in Oncology National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary complete response Up to 10 years
Primary prolonged progression-free survival Up to 10 years
Primary overall survival Up to 10 years
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