Study of Blood and Bone Marrow Samples in Patients With Chronic Myelogenous Leukemia Enrolled on a CALGB Clinical Trial

NCT ID: NCT01004640

Last Updated: 2023-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

1998-12-15

Brief Summary

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RATIONALE: Studying samples of blood and bone marrow from patients with cancer may help doctors identify biomarkers related to cancer.

PURPOSE: This research study is looking at blood and bone marrow samples in patients with chronic myelogenous leukemia enrolled on a CALGB clinical trial.

Detailed Description

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OBJECTIVES:

* Monitor molecular response rates of patients receiving treatment for chronic myelogenous leukemia by quantitative reverse transcription polymerase chain reaction (RT-PCR) and quantitative Southern blot monitoring of blood samples.
* Compare quantitative RT-PCR and quantitative Southern blot results with marrow cytogenetics at the time of complete molecular response in these patients.
* Monitor the frequency of residual disease in patients who achieve a complete blood Southern blot and marrow cytogenetic response (eradication of BCR/ABL by Southern blot and absence of the Philadelphia chromosome by cytogenetics).

OUTLINE: Peripheral blood samples and bone marrow aspirates are collected at baseline and at 3, 6, and 9 months after starting therapy. If patient continues to receive protocol treatment after 9 months, additional peripheral blood samples are collected every 6 months and bone marrow aspirates are taken annually. In the event of disease progression (blast crisis), an additional peripheral blood sample and bone marrow aspirate are collected.

Samples are examined by quantitative Southern blot analysis with probes to BCR, quantitative reverse transcriptase-polymerase chain reaction analysis for BCR/ABL fusion transcripts, and cytogenetic analysis.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 1.5 years.

Conditions

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Leukemia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Peripheral blood samples and bone marrow aspirates are collected at baseline and at 3, 6, and 9 months after starting therapy. If patient continues to receive protocol treatment after 9 months, additional peripheral blood samples are collected every 6 months and bone marrow aspirates are taken annually. In the event of disease progression (blast crisis), an additional peripheral blood sample and bone marrow aspirate are collected.

Samples are examined by quantitative Southern blot analysis with probes to BCR, quantitative reverse transcriptase-polymerase chain reaction analysis for BCR/ABL fusion transcripts, and cytogenetic analysis.

DNA analysis

Intervention Type GENETIC

Southern blotting

Intervention Type GENETIC

cytogenetic analysis

Intervention Type GENETIC

Correlative studies

polymerase chain reaction

Intervention Type GENETIC

Interventions

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DNA analysis

Intervention Type GENETIC

Southern blotting

Intervention Type GENETIC

cytogenetic analysis

Correlative studies

Intervention Type GENETIC

polymerase chain reaction

Intervention Type GENETIC

Other Intervention Names

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Laboratory Biomarker Analysis

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of chronic myelogenous leukemia (CML)
* Concurrent enrollment on a CALGB treatment protocol for newly diagnosed or previously treated CML (e.g, CLB-19804)

* Must not have initiated study therapy
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Alliance for Clinical Trials in Oncology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wendy Stock, MD

Role: STUDY_CHAIR

University of Chicago

Locations

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Naval Medical Center - San Diego

San Diego, California, United States

Site Status

UCSF Medical Center-Mount Zion

San Francisco, California, United States

Site Status

Beebe Medical Center

Lewes, Delaware, United States

Site Status

Christiana Care Health Services

Newark, Delaware, United States

Site Status

Nanticoke Memorial Hospital

Seaford, Delaware, United States

Site Status

Saint Francis Hospital - Wilmington

Wilmington, Delaware, United States

Site Status

Washington Hospital Center

Washington D.C., District of Columbia, United States

Site Status

Lombardi Comprehensive Cancer Center at Georgetown University Medical Center

Washington D.C., District of Columbia, United States

Site Status

Holy Cross Hospital

Fort Lauderdale, Florida, United States

Site Status

Broward Health Medical Center

Fort Lauderdale, Florida, United States

Site Status

Memorial Healthcare System - Joe DiMaggio Children's Hospital

Hollywood, Florida, United States

Site Status

Jupiter Medical Center

Jupiter, Florida, United States

Site Status

Mount Sinai Medical Center

Miami Beach, Florida, United States

Site Status

Illinois CancerCare-Bloomington

Bloomington, Illinois, United States

Site Status

Saint Joseph Medical Center

Bloomington, Illinois, United States

Site Status

Graham Hospital Assocation

Canton, Illinois, United States

Site Status

Illinois CancerCare-Canton

Canton, Illinois, United States

Site Status

Illinois CancerCare-Carthage

Carthage, Illinois, United States

Site Status

Memorial Hospital

Carthage, Illinois, United States

Site Status

Mount Sinai Hospital Medical Center

Chicago, Illinois, United States

Site Status

University of Illinois Cancer Center

Chicago, Illinois, United States

Site Status

Jesse Brown Veterans Affairs Medical Center

Chicago, Illinois, United States

Site Status

University of Chicago Cancer Research Center

Chicago, Illinois, United States

Site Status

Weiss Memorial Hospital

Chicago, Illinois, United States

Site Status

Eureka Hospital

Eureka, Illinois, United States

Site Status

Illinois CancerCare-Eureka

Eureka, Illinois, United States

Site Status

Galesburg Cottage Hospital

Galesburg, Illinois, United States

Site Status

Illinois CancerCare Galesburg

Galesburg, Illinois, United States

Site Status

Western Illinois Cancer Treatment Center

Galesburg, Illinois, United States

Site Status

Illinois CancerCare-Cottage

Galesburg, Illinois, United States

Site Status

Illinois Oncology Limited

Granite City, Illinois, United States

Site Status

Illinois CancerCare-Havana

Havana, Illinois, United States

Site Status

Mason District Hospital

Havana, Illinois, United States

Site Status

Hopedale Medical Complex - Hospital, Hopedale

Hopedale, Illinois, United States

Site Status

Illinois CancerCare-Kewanee Clinic

Kewanee, Illinois, United States

Site Status

Kewanee Hospital

Kewanee, Illinois, United States

Site Status

Illinois CancerCare-Macomb

Macomb, Illinois, United States

Site Status

Mcdonough District Hospital

Macomb, Illinois, United States

Site Status

Holy Family Medical Center

Monmouth, Illinois, United States

Site Status

Illinois CancerCare-Monmouth

Monmouth, Illinois, United States

Site Status

Community Cancer Center Foundation

Normal, Illinois, United States

Site Status

Illinois CancerCare-Community Cancer Center

Normal, Illinois, United States

Site Status

Bromenn Regional Medical Center

Normal, Illinois, United States

Site Status

Illinois CancerCare- Ottawa Clinic

Ottawa, Illinois, United States

Site Status

Ottwa Regional Hospital and Healthcare

Ottawa, Illinois, United States

Site Status

Illinois CancerCare- Pekin

Pekin, Illinois, United States

Site Status

Pekin Cancer Treatment Center

Pekin, Illinois, United States

Site Status

Pekin Hospital

Pekin, Illinois, United States

Site Status

Methodist Medical Center of Illinois

Peoria, Illinois, United States

Site Status

Proctor Hospital

Peoria, Illinois, United States

Site Status

Illinois CancerCare- Peoria

Peoria, Illinois, United States

Site Status

Illinois Oncology Research Association-CCOP

Peoria, Illinois, United States

Site Status

OSF Saint Francis Medical Center

Peoria, Illinois, United States

Site Status

Illinois CancerCare- Peru

Peru, Illinois, United States

Site Status

Illinois Valley Hospital

Peru, Illinois, United States

Site Status

Valley Radiation Oncology

Peru, Illinois, United States

Site Status

Illinois CancerCare- Princeton

Princeton, Illinois, United States

Site Status

Perry Memorial Hospital

Princeton, Illinois, United States

Site Status

Sarah Culberston Memorial Hospital

Rushville, Illinois, United States

Site Status

Illinois CancerCare- Spring Valley

Spring Valley, Illinois, United States

Site Status

Saint Margaret's Hospital

Spring Valley, Illinois, United States

Site Status

Elkhart General Hospital

Elkhart, Indiana, United States

Site Status

Fort Wayne Medical Oncology and Hematology

Fort Wayne, Indiana, United States

Site Status

Community Howard Regional Health

Kokomo, Indiana, United States

Site Status

IU Health La Porte Hospital

La Porte, Indiana, United States

Site Status

Saint Joseph Regional Medical Center - Mishawaka

Mishawaka, Indiana, United States

Site Status

Memorial Hospital of South Bend

South Bend, Indiana, United States

Site Status

Northern Indiana Cancer Research Consrtium

South Bend, Indiana, United States

Site Status

Physicians' Clinic of Iowa PC

Cedar Rapids, Iowa, United States

Site Status

Mercy Hospital

Cedar Rapids, Iowa, United States

Site Status

Saint Luke's Hospital

Cedar Rapids, Iowa, United States

Site Status

Holden Comprehensive Cancer Center at University of Iowa

Iowa City, Iowa, United States

Site Status

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Site Status

CancerCare of Maine at Eastern Maine Medical Center

Bangor, Maine, United States

Site Status

Eastern Maine Medical Center, Bangor

Bangor, Maine, United States

Site Status

Greenebaum Cancer Center at University of Maryland Medical Center

Baltimore, Maryland, United States

Site Status

University of Maryland/Greenebaum Cancer Center

Baltimore, Maryland, United States

Site Status

Union Hospital Cancer Program at Union Hospital

Elkton, Maryland, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status

Commonwealth Hematology Oncology PC-Worcester, Worcester

Worcester, Massachusetts, United States

Site Status

University of Massachusetts Medical School

Worcester, Massachusetts, United States

Site Status

Oncology Care Associates PLLC

Saint Joseph, Michigan, United States

Site Status

Missouri Cancer Associates

Columbia, Missouri, United States

Site Status

Veterans Administration

Columbia, Missouri, United States

Site Status

Ellis Fischel Cancer Center at University of Missouri - Columbia

Columbia, Missouri, United States

Site Status

University of Missouri - Ellis Fischel,

Columbia, Missouri, United States

Site Status

Capital Regional Medical Center

Jefferson City, Missouri, United States

Site Status

Lakeland Hospital

Saint Joseph, Missouri, United States

Site Status

Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Missouri Baptist Cancer Center

St Louis, Missouri, United States

Site Status

Missouri Baptist Medical Center

St Louis, Missouri, United States

Site Status

Arch Medical Services, Incorporated at Center for Cancer Care and Research

St Louis, Missouri, United States

Site Status

Center for Cancer Care and Research

St Louis, Missouri, United States

Site Status

Comprehensive Cancer Care, PC

St Louis, Missouri, United States

Site Status

University Medical Center of Southern Nevada

Las Vegas, Nevada, United States

Site Status

CCOP - Nevada Cancer Research Foundation

Las Vegas, Nevada, United States

Site Status

Nevada Cancer Research Foundation CCOP

Las Vegas, Nevada, United States

Site Status

Valley Regional

Claremont, New Hampshire, United States

Site Status

Cheshire Medical Center-Dartmouth-Hitchcock Keene

Keene, New Hampshire, United States

Site Status

Weeks Memorial Hospital

Lancaster, New Hampshire, United States

Site Status

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status

Alice Peck Day Memorial Hospital

Lebanon, New Hampshire, United States

Site Status

Frisbie Hospital

Rochester, New Hampshire, United States

Site Status

Cooper Hospital University Medical Center

Camden, New Jersey, United States

Site Status

Saint Barnabas Medical Center

Livingston, New Jersey, United States

Site Status

Cancer Institute of New Jersey at Cooper - Voorhees

Voorhees Township, New Jersey, United States

Site Status

Roswell Park Cancer Institute

Buffalo, New York, United States

Site Status

CCOP - Hematology-Oncology Associates of Central New York

East Syracuse, New York, United States

Site Status

Elmhurst Hospital Center

Elmhurst, New York, United States

Site Status

Glens Falls Hospital

Glens Falls, New York, United States

Site Status

Queens Hospital Center

Jamaica, New York, United States

Site Status

Mount Sinai Medical Center

New York, New York, United States

Site Status

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Site Status

Weill Medical College of Cornell University

New York, New York, United States

Site Status

Oswego Hospital

Oswego, New York, United States

Site Status

Stony Brook University Medical Center

Stony Brook, New York, United States

Site Status

Hematology Oncology Associates of Central New York-East Syracuse

Syracuse, New York, United States

Site Status

Saint Joseph's Hospital Health Center

Syracuse, New York, United States

Site Status

State University of New York Upstate Medical University

Syracuse, New York, United States

Site Status

SUNY Upstate Medical University Hospital

Syracuse, New York, United States

Site Status

Syracuse Veterans Administration Medical Center

Syracuse, New York, United States

Site Status

Veterans Affairs Medical Center - Syracuse

Syracuse, New York, United States

Site Status

Mission Hospital-Memorial Campus

Asheville, North Carolina, United States

Site Status

Mission Hospital-Saint Joseph Campus

Asheville, North Carolina, United States

Site Status

University of North Carolina

Chapel Hill, North Carolina, United States

Site Status

Carolinas Medical Center, Charlotte

Charlotte, North Carolina, United States

Site Status

Novant Health Presbyterian Medical Center

Charlotte, North Carolina, United States

Site Status

Duke University Medical Center

Durham, North Carolina, United States

Site Status

Wayne Memorial Hospital, Incorporated

Goldsboro, North Carolina, United States

Site Status

Kinston Medical Specialists

Kinston, North Carolina, United States

Site Status

Lenoir Memorial Hospital

Kinston, North Carolina, United States

Site Status

Wilson Medical Center

Wilson, North Carolina, United States

Site Status

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, United States

Site Status

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

Columbus, Ohio, United States

Site Status

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Site Status

Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital

Pittsburgh, Pennsylvania, United States

Site Status

West Penn Hospital

Pittsburgh, Pennsylvania, United States

Site Status

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Greenville Health System Cancer Institute-Easley

Easley, South Carolina, United States

Site Status

Saint Francis Hospital

Greenville, South Carolina, United States

Site Status

Greenville Health System Cancer Institute-Andrews

Greenville, South Carolina, United States

Site Status

Greenville Health System Cancer Institute-Butternut

Greenville, South Carolina, United States

Site Status

Greenville Health System Cancer Institute-Faris

Greenville, South Carolina, United States

Site Status

Greenville Memorial Hospital

Greenville, South Carolina, United States

Site Status

Greenville Health System Cancer Institute-Eastside

Greenville, South Carolina, United States

Site Status

Self Regional Healthcare

Greenwood, South Carolina, United States

Site Status

Cancer Centers of the Carolinas-Green Medial Oncology

Greer, South Carolina, United States

Site Status

Greenville Health System Cancer Institute-Seneca

Seneca, South Carolina, United States

Site Status

Greenville Health System Cancer Institute-Spartanburg

Spartanburg, South Carolina, United States

Site Status

Baptist Memorial Hospital and Cancer Center-Memphis

Memphis, Tennessee, United States

Site Status

Central Vermont Medical Center/ National Life Cancer Treatment

Berlin Corners, Vermont, United States

Site Status

Fletcher Allen Health Care - University Health Center Campus

Burlington, Vermont, United States

Site Status

University of Vermont College of Medicine

Burlington, Vermont, United States

Site Status

North Country Health

Newport, Vermont, United States

Site Status

Northeastern

Saint Johnsbury, Vermont, United States

Site Status

Springfield Hospital

Springfield, Vermont, United States

Site Status

White River Junction Veteran Administration Medical Center

White River Junction, Vermont, United States

Site Status

Danville Regional Medical Center

Danville, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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U10CA031946

Identifier Type: NIH

Identifier Source: secondary_id

View Link

U10CA180821

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CDR0000078595

Identifier Type: REGISTRY

Identifier Source: secondary_id

CALGB-29801

Identifier Type: -

Identifier Source: org_study_id

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