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

This study has suspended participant recruitment.
(Trial suspension due to NCI NCTN transition.)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT01005368
First received: October 29, 2009
Last updated: July 9, 2015
Last verified: July 2015
  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
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Molecular Markers Of Chronic Lymphocytic Leukemia

Resource links provided by NLM:


Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • complete response [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
  • prolonged progression-free survival [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
  • overall survival [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

blood and bone marrow samples


Estimated Enrollment: 600
Study Start Date: October 2009
Estimated Primary Completion Date: January 2100 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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
Sampling Method:   Non-Probability Sample
Study Population

Patients diagnosed with chronic lymphocytic leukemia and were previously untreated. The patients must have also previously enrolled on a Cancer and Leukemia Group B protocol.

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
San Diego, California, United States, 92108
United States, Delaware
Tunnell Cancer Center at Beebe Medical Center
Lewes, Delaware, United States, 19958
CCOP - Christiana Care Health Services
Newark, Delaware, United States, 19713
United States, District of Columbia
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
Washington, District of Columbia, United States, 20007
United States, Illinois
Louis A. Weiss Memorial Hospital
Chicago, Illinois, United States, 60640
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
United States, Indiana
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, United States, 46845
United States, Iowa
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States, 52242-1002
United States, Maine
Harold Alfond Center for Cancer Care
Augusta, Maine, United States, 04330
CancerCare of Maine at Eastern Maine Medical Center
Bangor, Maine, United States, 04401
United States, Maryland
National Naval Medical Center
Bethesda, Maryland, United States, 20889-5600
Union Hospital of Cecil County
Elkton MD, Maryland, United States, 21921
United States, Minnesota
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, United States, 55417
United States, Missouri
Southeast Cancer Center
Cape Girardeau, Missouri, United States, 63703
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, United States, 65203
Goldschmidt Cancer Center
Jefferson City, Missouri, United States, 65109
Missouri Baptist Cancer Center
Saint Louis, Missouri, United States, 63131
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
Saint Louis, Missouri, United States, 63110
United States, Nebraska
Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center
Grand Island, Nebraska, United States, 68803
Callahan Cancer Center at Great Plains Regional Medical Center
North Platte, Nebraska, United States, 69103
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-6805
United States, New Jersey
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees, New Jersey, United States, 08043
United States, New York
CCOP - Hematology-Oncology Associates of Central New York
East Syracuse, New York, United States, 13057
New York Weill Cornell Cancer Center at Cornell University
New York, New York, United States, 10021
SUNY Upstate Medical University Hospital
Syracuse, New York, United States, 13210
United States, North Carolina
Presbyterian Cancer Center at Presbyterian Hospital
Charlotte, North Carolina, United States, 28233-3549
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, United States, 27534
Pardee Memorial Hospital
Hendersonville, North Carolina, United States, 28791
Kinston Medical Specialists
Kinston, North Carolina, United States, 28501
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096
United States, Ohio
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210-1240
United States, Pennsylvania
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States, 15224-1791
United States, South Carolina
McLeod Regional Medical Center
Florence, South Carolina, United States, 29501
United States, Vermont
Mountainview Medical
Berlin, Vermont, United States, 05602
Fletcher Allen Health Care - University Health Center Campus
Burlington, Vermont, United States, 05401
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
Investigators
Study Chair: John C. Byrd, MD Ohio State University Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT01005368     History of Changes
Other Study ID Numbers: CALGB-20203, CALGB-20203, CDR0000398201
Study First Received: October 29, 2009
Last Updated: July 9, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Alliance for Clinical Trials in Oncology:
chronic lymphocytic leukemia

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

ClinicalTrials.gov processed this record on August 03, 2015