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
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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UNKNOWN
60 participants
OBSERVATIONAL
1998-12-15
Brief Summary
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PURPOSE: This research study is looking at blood and bone marrow samples in patients with chronic myelogenous leukemia enrolled on a CALGB clinical trial.
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Detailed Description
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* 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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Study Design
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CASE_ONLY
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
Southern blotting
cytogenetic analysis
Correlative studies
polymerase chain reaction
Interventions
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DNA analysis
Southern blotting
cytogenetic analysis
Correlative studies
polymerase chain reaction
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Concurrent enrollment on a CALGB treatment protocol for newly diagnosed or previously treated CML (e.g, CLB-19804)
* Must not have initiated study therapy
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
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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
UCSF Medical Center-Mount Zion
San Francisco, California, United States
Beebe Medical Center
Lewes, Delaware, United States
Christiana Care Health Services
Newark, Delaware, United States
Nanticoke Memorial Hospital
Seaford, Delaware, United States
Saint Francis Hospital - Wilmington
Wilmington, Delaware, United States
Washington Hospital Center
Washington D.C., District of Columbia, United States
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
Washington D.C., District of Columbia, United States
Holy Cross Hospital
Fort Lauderdale, Florida, United States
Broward Health Medical Center
Fort Lauderdale, Florida, United States
Memorial Healthcare System - Joe DiMaggio Children's Hospital
Hollywood, Florida, United States
Jupiter Medical Center
Jupiter, Florida, United States
Mount Sinai Medical Center
Miami Beach, Florida, United States
Illinois CancerCare-Bloomington
Bloomington, Illinois, United States
Saint Joseph Medical Center
Bloomington, Illinois, United States
Graham Hospital Assocation
Canton, Illinois, United States
Illinois CancerCare-Canton
Canton, Illinois, United States
Illinois CancerCare-Carthage
Carthage, Illinois, United States
Memorial Hospital
Carthage, Illinois, United States
Mount Sinai Hospital Medical Center
Chicago, Illinois, United States
University of Illinois Cancer Center
Chicago, Illinois, United States
Jesse Brown Veterans Affairs Medical Center
Chicago, Illinois, United States
University of Chicago Cancer Research Center
Chicago, Illinois, United States
Weiss Memorial Hospital
Chicago, Illinois, United States
Eureka Hospital
Eureka, Illinois, United States
Illinois CancerCare-Eureka
Eureka, Illinois, United States
Galesburg Cottage Hospital
Galesburg, Illinois, United States
Illinois CancerCare Galesburg
Galesburg, Illinois, United States
Western Illinois Cancer Treatment Center
Galesburg, Illinois, United States
Illinois CancerCare-Cottage
Galesburg, Illinois, United States
Illinois Oncology Limited
Granite City, Illinois, United States
Illinois CancerCare-Havana
Havana, Illinois, United States
Mason District Hospital
Havana, Illinois, United States
Hopedale Medical Complex - Hospital, Hopedale
Hopedale, Illinois, United States
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, United States
Kewanee Hospital
Kewanee, Illinois, United States
Illinois CancerCare-Macomb
Macomb, Illinois, United States
Mcdonough District Hospital
Macomb, Illinois, United States
Holy Family Medical Center
Monmouth, Illinois, United States
Illinois CancerCare-Monmouth
Monmouth, Illinois, United States
Community Cancer Center Foundation
Normal, Illinois, United States
Illinois CancerCare-Community Cancer Center
Normal, Illinois, United States
Bromenn Regional Medical Center
Normal, Illinois, United States
Illinois CancerCare- Ottawa Clinic
Ottawa, Illinois, United States
Ottwa Regional Hospital and Healthcare
Ottawa, Illinois, United States
Illinois CancerCare- Pekin
Pekin, Illinois, United States
Pekin Cancer Treatment Center
Pekin, Illinois, United States
Pekin Hospital
Pekin, Illinois, United States
Methodist Medical Center of Illinois
Peoria, Illinois, United States
Proctor Hospital
Peoria, Illinois, United States
Illinois CancerCare- Peoria
Peoria, Illinois, United States
Illinois Oncology Research Association-CCOP
Peoria, Illinois, United States
OSF Saint Francis Medical Center
Peoria, Illinois, United States
Illinois CancerCare- Peru
Peru, Illinois, United States
Illinois Valley Hospital
Peru, Illinois, United States
Valley Radiation Oncology
Peru, Illinois, United States
Illinois CancerCare- Princeton
Princeton, Illinois, United States
Perry Memorial Hospital
Princeton, Illinois, United States
Sarah Culberston Memorial Hospital
Rushville, Illinois, United States
Illinois CancerCare- Spring Valley
Spring Valley, Illinois, United States
Saint Margaret's Hospital
Spring Valley, Illinois, United States
Elkhart General Hospital
Elkhart, Indiana, United States
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, United States
Community Howard Regional Health
Kokomo, Indiana, United States
IU Health La Porte Hospital
La Porte, Indiana, United States
Saint Joseph Regional Medical Center - Mishawaka
Mishawaka, Indiana, United States
Memorial Hospital of South Bend
South Bend, Indiana, United States
Northern Indiana Cancer Research Consrtium
South Bend, Indiana, United States
Physicians' Clinic of Iowa PC
Cedar Rapids, Iowa, United States
Mercy Hospital
Cedar Rapids, Iowa, United States
Saint Luke's Hospital
Cedar Rapids, Iowa, United States
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
CancerCare of Maine at Eastern Maine Medical Center
Bangor, Maine, United States
Eastern Maine Medical Center, Bangor
Bangor, Maine, United States
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, United States
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, United States
Union Hospital Cancer Program at Union Hospital
Elkton, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Commonwealth Hematology Oncology PC-Worcester, Worcester
Worcester, Massachusetts, United States
University of Massachusetts Medical School
Worcester, Massachusetts, United States
Oncology Care Associates PLLC
Saint Joseph, Michigan, United States
Missouri Cancer Associates
Columbia, Missouri, United States
Veterans Administration
Columbia, Missouri, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, United States
University of Missouri - Ellis Fischel,
Columbia, Missouri, United States
Capital Regional Medical Center
Jefferson City, Missouri, United States
Lakeland Hospital
Saint Joseph, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Missouri Baptist Cancer Center
St Louis, Missouri, United States
Missouri Baptist Medical Center
St Louis, Missouri, United States
Arch Medical Services, Incorporated at Center for Cancer Care and Research
St Louis, Missouri, United States
Center for Cancer Care and Research
St Louis, Missouri, United States
Comprehensive Cancer Care, PC
St Louis, Missouri, United States
University Medical Center of Southern Nevada
Las Vegas, Nevada, United States
CCOP - Nevada Cancer Research Foundation
Las Vegas, Nevada, United States
Nevada Cancer Research Foundation CCOP
Las Vegas, Nevada, United States
Valley Regional
Claremont, New Hampshire, United States
Cheshire Medical Center-Dartmouth-Hitchcock Keene
Keene, New Hampshire, United States
Weeks Memorial Hospital
Lancaster, New Hampshire, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
Alice Peck Day Memorial Hospital
Lebanon, New Hampshire, United States
Frisbie Hospital
Rochester, New Hampshire, United States
Cooper Hospital University Medical Center
Camden, New Jersey, United States
Saint Barnabas Medical Center
Livingston, New Jersey, United States
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees Township, New Jersey, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
CCOP - Hematology-Oncology Associates of Central New York
East Syracuse, New York, United States
Elmhurst Hospital Center
Elmhurst, New York, United States
Glens Falls Hospital
Glens Falls, New York, United States
Queens Hospital Center
Jamaica, New York, United States
Mount Sinai Medical Center
New York, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Weill Medical College of Cornell University
New York, New York, United States
Oswego Hospital
Oswego, New York, United States
Stony Brook University Medical Center
Stony Brook, New York, United States
Hematology Oncology Associates of Central New York-East Syracuse
Syracuse, New York, United States
Saint Joseph's Hospital Health Center
Syracuse, New York, United States
State University of New York Upstate Medical University
Syracuse, New York, United States
SUNY Upstate Medical University Hospital
Syracuse, New York, United States
Syracuse Veterans Administration Medical Center
Syracuse, New York, United States
Veterans Affairs Medical Center - Syracuse
Syracuse, New York, United States
Mission Hospital-Memorial Campus
Asheville, North Carolina, United States
Mission Hospital-Saint Joseph Campus
Asheville, North Carolina, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Carolinas Medical Center, Charlotte
Charlotte, North Carolina, United States
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, United States
Kinston Medical Specialists
Kinston, North Carolina, United States
Lenoir Memorial Hospital
Kinston, North Carolina, United States
Wilson Medical Center
Wilson, North Carolina, United States
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States
West Penn Hospital
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Greenville Health System Cancer Institute-Easley
Easley, South Carolina, United States
Saint Francis Hospital
Greenville, South Carolina, United States
Greenville Health System Cancer Institute-Andrews
Greenville, South Carolina, United States
Greenville Health System Cancer Institute-Butternut
Greenville, South Carolina, United States
Greenville Health System Cancer Institute-Faris
Greenville, South Carolina, United States
Greenville Memorial Hospital
Greenville, South Carolina, United States
Greenville Health System Cancer Institute-Eastside
Greenville, South Carolina, United States
Self Regional Healthcare
Greenwood, South Carolina, United States
Cancer Centers of the Carolinas-Green Medial Oncology
Greer, South Carolina, United States
Greenville Health System Cancer Institute-Seneca
Seneca, South Carolina, United States
Greenville Health System Cancer Institute-Spartanburg
Spartanburg, South Carolina, United States
Baptist Memorial Hospital and Cancer Center-Memphis
Memphis, Tennessee, United States
Central Vermont Medical Center/ National Life Cancer Treatment
Berlin Corners, Vermont, United States
Fletcher Allen Health Care - University Health Center Campus
Burlington, Vermont, United States
University of Vermont College of Medicine
Burlington, Vermont, United States
North Country Health
Newport, Vermont, United States
Northeastern
Saint Johnsbury, Vermont, United States
Springfield Hospital
Springfield, Vermont, United States
White River Junction Veteran Administration Medical Center
White River Junction, Vermont, United States
Danville Regional Medical Center
Danville, Virginia, United States
Countries
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Other Identifiers
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