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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by National Cancer Institute (NCI)
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01005368
First received: October 29, 2009
Last updated: February 17, 2013
Last verified: February 2013
  Purpose

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 Intervention
Leukemia
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

Study Type: Observational
Official Title: Molecular Markers Of Chronic Lymphocytic Leukemia

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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) [ Designated as safety issue: No ]
  • Significance of absence of IgVH gene mutational status as related to the ability to predict CR, PFS, and OS [ Designated as safety issue: No ]
  • Correlation of IgVH gene mutational status with CD38 and ZAP-70 expression, over-expression of Mcl-1, BAK-1, high Mcl-1:Bax ratio, p53 mutation or dysfunction, high-risk karyotype abnormalities, other molecular features associated with poor outcome [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]
  • Clonal evolution [ Designated as safety issue: No ]

Estimated Enrollment: 600
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01005368

  Hide Study Locations
Locations
United States, California
Kaiser Permanente Medical Office -Vandever Medical Office Recruiting
San Diego, California, United States, 92108
Contact: Han A. Koh    619-528-2596      
United States, Delaware
Tunnell Cancer Center at Beebe Medical Center Recruiting
Lewes, Delaware, United States, 19958
Contact: Clinical Trials Office - Tunnell Cancer Center    302-645-3171      
CCOP - Christiana Care Health Services Recruiting
Newark, Delaware, United States, 19713
Contact: Clinical Trial Office - CCOP - Christiana Care Health Services    302-623-4450      
United States, District of Columbia
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center Recruiting
Washington, District of Columbia, United States, 20007
Contact: Clinical Trials Office - Lombardi Comprehensive Cancer Center    202-444-0381      
United States, Illinois
Louis A. Weiss Memorial Hospital Recruiting
Chicago, Illinois, United States, 60640
Contact: Clinical Trials Office - Louis A. Weiss Memorial Hospital    773-564-5044      
University of Chicago Cancer Research Center Recruiting
Chicago, Illinois, United States, 60637-1470
Contact: Clinical Trials Office - University of Chicago Cancer Research    773-834-7424      
United States, Indiana
Fort Wayne Medical Oncology and Hematology Recruiting
Fort Wayne, Indiana, United States, 46845
Contact: Sreenivasa R. Nattam, MD    260-484-8830      
United States, Iowa
Holden Comprehensive Cancer Center at University of Iowa Recruiting
Iowa City, Iowa, United States, 52242-1002
Contact: Cancer Information Service    800-237-1225      
United States, Maine
Harold Alfond Center for Cancer Care Recruiting
Augusta, Maine, United States, 04330
Contact: Thomas H. Openshaw    207-621-6100      
CancerCare of Maine at Eastern Maine Medical Center Recruiting
Bangor, Maine, United States, 04401
Contact: Clinical Trials Office - CancerCare of Maine    207-973-4274      
United States, Maryland
National Naval Medical Center Recruiting
Bethesda, Maryland, United States, 20889-5600
Contact: David C. Van Echo    301-295-5706      
Union Hospital of Cecil County Recruiting
Elkton MD, Maryland, United States, 21921
Contact: Stephen S. Grubbs, MD    302-366-1200      
United States, Minnesota
Veterans Affairs Medical Center - Minneapolis Recruiting
Minneapolis, Minnesota, United States, 55417
Contact: Clinical Trials Office - Veterans Affairs Medical Center - Min    612-467-2800      
United States, Missouri
Southeast Cancer Center Recruiting
Cape Girardeau, Missouri, United States, 63703
Contact: Alan P. Lyss, MD    314-996-5514      
Ellis Fischel Cancer Center at University of Missouri - Columbia Recruiting
Columbia, Missouri, United States, 65203
Contact: Clinical Trial Office - Ellis Fischel Cancer Center    573-882-7440      
Goldschmidt Cancer Center Recruiting
Jefferson City, Missouri, United States, 65109
Contact: Alan P. Lyss, MD    314-996-5514      
Missouri Baptist Cancer Center Recruiting
Saint Louis, Missouri, United States, 63131
Contact: Alan P. Lyss, MD    314-996-5514      
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Nancy L. Bartlett, MD    314-362-5654      
United States, Nebraska
Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center Recruiting
Grand Island, Nebraska, United States, 68803
Contact: Robert Bociek, MD    402-559-9053      
Callahan Cancer Center at Great Plains Regional Medical Center Recruiting
North Platte, Nebraska, United States, 69103
Contact: Clinical Trials Office - Callahan Cancer Center at Great Plain    308-696-7864      
UNMC Eppley Cancer Center at the University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198-6805
Contact: Clinical Trials Office - UNMC Eppley Cancer Center at the Univ    800-999-5465      
United States, New Jersey
Cancer Institute of New Jersey at Cooper - Voorhees Recruiting
Voorhees, New Jersey, United States, 08043
Contact: Clinical Trials Office - Cancer Institute of New Jersey at Coo    856-325-6757      
United States, New York
CCOP - Hematology-Oncology Associates of Central New York Recruiting
East Syracuse, New York, United States, 13057
Contact: Jeffrey J. Kirshner, MD    315-472-7504      
New York Weill Cornell Cancer Center at Cornell University Recruiting
New York, New York, United States, 10021
Contact: Clinical Trials Office - New York Weill Cornell Cancer Center    212-746-1848      
SUNY Upstate Medical University Hospital Recruiting
Syracuse, New York, United States, 13210
Contact: Clinical Trials Office - SUNY Upstate Medical University Hospi    315-464-5476      
United States, North Carolina
Presbyterian Cancer Center at Presbyterian Hospital Recruiting
Charlotte, North Carolina, United States, 28233-3549
Contact: Clinical Trials Office - Presbyterian Cancer Center at Presbyt    704-384-5369      
Wayne Memorial Hospital, Incorporated Recruiting
Goldsboro, North Carolina, United States, 27534
Contact: James N. Atkins, MD    919-580-0000      
Pardee Memorial Hospital Recruiting
Hendersonville, North Carolina, United States, 28791
Contact: James E. Radford, MD    828-692-8045      
Kinston Medical Specialists Recruiting
Kinston, North Carolina, United States, 28501
Contact: Peter R. Watson, MD    252-559-2200ext.201      
Wake Forest University Comprehensive Cancer Center Recruiting
Winston-Salem, North Carolina, United States, 27157-1096
Contact: Clinical Trials Office - Wake Forest University Comprehensive    336-713-6771      
United States, Ohio
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center Recruiting
Columbus, Ohio, United States, 43210-1240
Contact: Ohio State University Cancer Clinical Trial Matching Service    866-627-7616    Jamesline@osumc.edu   
United States, Pennsylvania
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15224-1791
Contact: John Lister    412-578-5000      
United States, South Carolina
McLeod Regional Medical Center Recruiting
Florence, South Carolina, United States, 29501
Contact: Clinical Trials Office - McLeod Regional Medical Center    843-679-7256      
United States, Vermont
Mountainview Medical Recruiting
Berlin, Vermont, United States, 05602
Contact: Gurpreet Lamba    802-223-6196      
Fletcher Allen Health Care - University Health Center Campus Recruiting
Burlington, Vermont, United States, 05401
Contact: Clinical Trials Office - Fletcher Allen Health Care    802-656-8990      
Sponsors and Collaborators
Cancer and Leukemia Group B
Investigators
Study Chair: John C. Byrd, MD Ohio State University Comprehensive Cancer Center
Investigator: Nyla Heerema, PhD Ohio State University Comprehensive Cancer Center
Investigator: John G. Gribben, MD, DSc Dana-Farber Cancer Institute
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT01005368     History of Changes
Other Study ID Numbers: CDR0000398201, CALGB-20203
Study First Received: October 29, 2009
Last Updated: February 17, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
chronic lymphocytic leukemia

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on August 21, 2014