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

August 2, 2022 updated by: Alliance for Clinical Trials in Oncology

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.
Other: laboratory biomarker analysis
Genetic: mutation analysis
Other: flow cytometry
Genetic: polymerase chain reaction
Genetic: fluorescence in situ hybridization
Genetic: western blotting
Genetic: nucleic acid sequencing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: Up to 10 years
Up to 10 years
complete response
Time Frame: Up to 10 years
Up to 10 years
prolonged progression-free survival
Time Frame: Up to 10 years
Up to 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alliance for Clinical Trials in Oncology

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: John C. Byrd, MD, Ohio State University Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2009

Primary Completion (Actual)

April 1, 2022

Study Completion (Actual)

April 1, 2022

Study Registration Dates

First Submitted

October 29, 2009

First Submitted That Met QC Criteria

October 29, 2009

First Posted (Estimate)

October 30, 2009

Study Record Updates

Last Update Posted (Actual)

August 3, 2022

Last Update Submitted That Met QC Criteria

August 2, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CALGB-20203
  • CDR0000398201 (Registry Identifier: NCI Physician Data Query)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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