Study of Biomarkers in Blood and Bone Marrow Samples From Patients With Previously Untreated Chronic Lymphocytic Leukemia
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
OBJECTIVES:
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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.
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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.
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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.
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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.
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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 Design
Arms and Interventions
| Arm | 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. |
Genetic: fluorescence in situ hybridization
Genetic: mutation analysis
Genetic: nucleic acid sequencing
Genetic: polymerase chain reaction
Genetic: western blotting
Other: flow cytometry
Other: laboratory biomarker analysis
|
Outcome Measures
Primary Outcome Measures
- complete response [Up to 10 years]
- prolonged progression-free survival [Up to 10 years]
- overall survival [Up to 10 years]
Eligibility Criteria
Criteria
DISEASE CHARACTERISTICS:
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Diagnosis of chronic lymphocytic leukemia
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Previously untreated disease
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Registered to receive treatment on a Cancer and Leukemia Group B protocol
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Kaiser Permanente Medical Office -Vandever Medical Office | San Diego | California | United States | 92108 |
| 2 | Tunnell Cancer Center at Beebe Medical Center | Lewes | Delaware | United States | 19958 |
| 3 | CCOP - Christiana Care Health Services | Newark | Delaware | United States | 19713 |
| 4 | Lombardi Comprehensive Cancer Center at Georgetown University Medical Center | Washington | District of Columbia | United States | 20007 |
| 5 | University of Chicago Cancer Research Center | Chicago | Illinois | United States | 60637-1470 |
| 6 | Louis A. Weiss Memorial Hospital | Chicago | Illinois | United States | 60640 |
| 7 | Fort Wayne Medical Oncology and Hematology | Fort Wayne | Indiana | United States | 46845 |
| 8 | Holden Comprehensive Cancer Center at University of Iowa | Iowa City | Iowa | United States | 52242-1002 |
| 9 | Harold Alfond Center for Cancer Care | Augusta | Maine | United States | 04330 |
| 10 | CancerCare of Maine at Eastern Maine Medical Center | Bangor | Maine | United States | 04401 |
| 11 | National Naval Medical Center | Bethesda | Maryland | United States | 20889-5600 |
| 12 | Union Hospital of Cecil County | Elkton | Maryland | United States | 21921 |
| 13 | Veterans Affairs Medical Center - Minneapolis | Minneapolis | Minnesota | United States | 55417 |
| 14 | Southeast Cancer Center | Cape Girardeau | Missouri | United States | 63703 |
| 15 | Ellis Fischel Cancer Center at University of Missouri - Columbia | Columbia | Missouri | United States | 65203 |
| 16 | Goldschmidt Cancer Center | Jefferson City | Missouri | United States | 65109 |
| 17 | Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | Saint Louis | Missouri | United States | 63110 |
| 18 | Missouri Baptist Cancer Center | Saint Louis | Missouri | United States | 63131 |
| 19 | Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center | Grand Island | Nebraska | United States | 68803 |
| 20 | Callahan Cancer Center at Great Plains Regional Medical Center | North Platte | Nebraska | United States | 69103 |
| 21 | UNMC Eppley Cancer Center at the University of Nebraska Medical Center | Omaha | Nebraska | United States | 68198-6805 |
| 22 | Cancer Institute of New Jersey at Cooper - Voorhees | Voorhees | New Jersey | United States | 08043 |
| 23 | CCOP - Hematology-Oncology Associates of Central New York | East Syracuse | New York | United States | 13057 |
| 24 | New York Weill Cornell Cancer Center at Cornell University | New York | New York | United States | 10021 |
| 25 | SUNY Upstate Medical University Hospital | Syracuse | New York | United States | 13210 |
| 26 | Presbyterian Cancer Center at Presbyterian Hospital | Charlotte | North Carolina | United States | 28233-3549 |
| 27 | Wayne Memorial Hospital, Incorporated | Goldsboro | North Carolina | United States | 27534 |
| 28 | Pardee Memorial Hospital | Hendersonville | North Carolina | United States | 28791 |
| 29 | Kinston Medical Specialists | Kinston | North Carolina | United States | 28501 |
| 30 | Wake Forest University Comprehensive Cancer Center | Winston-Salem | North Carolina | United States | 27157-1096 |
| 31 | Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center | Columbus | Ohio | United States | 43210-1240 |
| 32 | Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital | Pittsburgh | Pennsylvania | United States | 15224-1791 |
| 33 | McLeod Regional Medical Center | Florence | South Carolina | United States | 29501 |
| 34 | Mountainview Medical | Berlin | Vermont | United States | 05602 |
| 35 | Fletcher Allen Health Care - University Health Center Campus | Burlington | Vermont | United States | 05401 |
Sponsors and Collaborators
- Alliance for Clinical Trials in Oncology
- National Cancer Institute (NCI)
Investigators
- Study Chair: John C. Byrd, MD, Ohio State University Comprehensive Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CALGB-20203
- CALGB-20203
- CDR0000398201