Study of Blood and Bone Marrow Samples in Patients With Chronic Myelogenous Leukemia Enrolled on a CALGB Clinical Trial
- Conditions
- Leukemia
- Interventions
- Genetic: DNA analysisGenetic: Southern blottingGenetic: cytogenetic analysisGenetic: polymerase chain reaction
- Registration Number
- NCT01004640
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 60
-
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
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Group 1 DNA analysis 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. Group 1 cytogenetic analysis 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. Group 1 polymerase chain reaction 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. Group 1 Southern blotting 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.
- Primary Outcome Measures
Name Time Method Frequency of residual disease in patients who have achieved a complete response Up to 12 months Distribution of RT-PCR response or Southern blot response Up to 1.5 years Distribution response Up to 1.5 years Distribution of cytogenetic response Up to 1.5 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (160)
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
Greenville Health System Cancer Institute-Easley
🇺🇸Easley, South Carolina, United States
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
West Penn Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Illinois CancerCare Galesburg
🇺🇸Galesburg, Illinois, United States
Illinois CancerCare-Havana
🇺🇸Havana, Illinois, United States
Memorial Hospital
🇺🇸Carthage, Illinois, United States
Eureka Hospital
🇺🇸Eureka, Illinois, United States
Illinois CancerCare- Princeton
🇺🇸Princeton, Illinois, United States
Galesburg Cottage Hospital
🇺🇸Galesburg, Illinois, United States
Mcdonough District Hospital
🇺🇸Macomb, Illinois, United States
Fort Wayne Medical Oncology and Hematology
🇺🇸Fort Wayne, Indiana, United States
Western Illinois Cancer Treatment Center
🇺🇸Galesburg, Illinois, United States
Elkhart General Hospital
🇺🇸Elkhart, Indiana, United States
CancerCare of Maine at Eastern Maine Medical Center
🇺🇸Bangor, Maine, United States
Eastern Maine Medical Center, Bangor
🇺🇸Bangor, Maine, United States
Saint Barnabas Medical Center
🇺🇸Livingston, New Jersey, United States
Cancer Institute of New Jersey at Cooper - Voorhees
🇺🇸Voorhees, New Jersey, United States
Mount Sinai Hospital Medical Center
🇺🇸Chicago, Illinois, United States
Jesse Brown Veterans Affairs Medical Center
🇺🇸Chicago, Illinois, United States
Saint Joseph Medical Center
🇺🇸Bloomington, Illinois, United States
Missouri Baptist Medical Center
🇺🇸Saint Louis, Missouri, United States
Arch Medical Services, Incorporated at Center for Cancer Care and Research
🇺🇸Saint Louis, Missouri, United States
Fletcher Allen Health Care - University Health Center Campus
🇺🇸Burlington, Vermont, United States
White River Junction Veteran Administration Medical Center
🇺🇸White River Junction, Vermont, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
University Medical Center of Southern Nevada
🇺🇸Las Vegas, Nevada, United States
Naval Medical Center - San Diego
🇺🇸San Diego, California, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, 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
Saint Francis Hospital - Wilmington
🇺🇸Wilmington, Delaware, United States
Nanticoke Memorial Hospital
🇺🇸Seaford, Delaware, United States
Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
Mount Sinai Medical Center
🇺🇸New York, New York, United States
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
🇺🇸Washington, District of Columbia, United States
Holy Cross Hospital
🇺🇸Fort Lauderdale, Florida, United States
Broward Health Medical Center
🇺🇸Fort Lauderdale, Florida, United States
Jupiter Medical Center
🇺🇸Jupiter, Florida, United States
Memorial Healthcare System - Joe DiMaggio Children's Hospital
🇺🇸Hollywood, Florida, United States
Graham Hospital Assocation
🇺🇸Canton, Illinois, United States
Illinois CancerCare-Bloomington
🇺🇸Bloomington, Illinois, United States
Illinois CancerCare-Canton
🇺🇸Canton, Illinois, United States
University of Illinois Cancer Center
🇺🇸Chicago, Illinois, United States
Illinois CancerCare-Carthage
🇺🇸Carthage, Illinois, United States
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
Weiss Memorial Hospital
🇺🇸Chicago, Illinois, United States
Illinois CancerCare-Eureka
🇺🇸Eureka, Illinois, United States
Illinois CancerCare-Cottage
🇺🇸Galesburg, Illinois, United States
Mason District Hospital
🇺🇸Havana, Illinois, United States
Illinois Oncology Limited
🇺🇸Granite City, Illinois, United States
Hopedale Medical Complex - Hospital, Hopedale
🇺🇸Hopedale, Illinois, United States
Holy Family Medical Center
🇺🇸Monmouth, Illinois, United States
Illinois CancerCare-Macomb
🇺🇸Macomb, Illinois, United States
Illinois CancerCare-Monmouth
🇺🇸Monmouth, Illinois, United States
Kewanee Hospital
🇺🇸Kewanee, Illinois, United States
Bromenn Regional Medical Center
🇺🇸Normal, Illinois, United States
Illinois CancerCare- Ottawa Clinic
🇺🇸Ottawa, Illinois, United States
Community Cancer Center Foundation
🇺🇸Normal, Illinois, United States
Methodist Medical Center of Illinois
🇺🇸Peoria, Illinois, United States
Proctor Hospital
🇺🇸Peoria, Illinois, United States
Pekin Hospital
🇺🇸Pekin, 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
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
Community Howard Regional Health
🇺🇸Kokomo, Indiana, United States
Memorial Hospital of South Bend
🇺🇸South Bend, Indiana, United States
IU Health La Porte Hospital
🇺🇸La Porte, Indiana, United States
Saint Joseph Regional Medical Center - Mishawaka
🇺🇸Mishawaka, Indiana, United States
Northern Indiana Cancer Research Consrtium
🇺🇸South Bend, Indiana, United States
Physicians' Clinic of Iowa PC
🇺🇸Cedar Rapids, Iowa, United States
Saint Luke's Hospital
🇺🇸Cedar Rapids, Iowa, United States
University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States
Holden Comprehensive Cancer Center at University of Iowa
🇺🇸Iowa City, Iowa, United States
Mercy Hospital
🇺🇸Cedar Rapids, Iowa, United States
University of Maryland/Greenebaum Cancer Center
🇺🇸Baltimore, Maryland, United States
Greenebaum Cancer Center at University of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States
Union Hospital Cancer Program at Union Hospital
🇺🇸Elkton, Maryland, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Commonwealth Hematology Oncology PC-Worcester, Worcester
🇺🇸Worcester, Massachusetts, United States
Missouri Cancer Associates
🇺🇸Columbia, Missouri, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia
🇺🇸Columbia, Missouri, United States
University of Massachusetts Medical School
🇺🇸Worcester, Massachusetts, United States
Oncology Care Associates PLLC
🇺🇸Saint Joseph, Michigan, United States
Lakeland Hospital
🇺🇸Saint Joseph, Missouri, United States
Capital Regional Medical Center
🇺🇸Jefferson City, Missouri, United States
Missouri Baptist Cancer Center
🇺🇸Saint Louis, Missouri, United States
Center for Cancer Care and Research
🇺🇸Saint Louis, Missouri, United States
CCOP - Nevada Cancer Research Foundation
🇺🇸Las Vegas, Nevada, United States
Nevada Cancer Research Foundation CCOP
🇺🇸Las Vegas, Nevada, United States
Comprehensive Cancer Care, PC
🇺🇸Saint Louis, Missouri, United States
Valley Regional
🇺🇸Claremont, New Hampshire, United States
Weeks Memorial Hospital
🇺🇸Lancaster, 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
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
Oswego Hospital
🇺🇸Oswego, New York, United States
Queens Hospital Center
🇺🇸Jamaica, New York, United States
Weill Medical College of Cornell University
🇺🇸New York, New York, United States
Stony Brook University Medical Center
🇺🇸Stony Brook, New York, United States
Syracuse Veterans Administration Medical Center
🇺🇸Syracuse, New York, United States
State University of New York Upstate Medical University
🇺🇸Syracuse, New York, United States
Hematology Oncology Associates of Central New York-East Syracuse
🇺🇸Syracuse, New York, United States
Novant Health Presbyterian Medical Center
🇺🇸Charlotte, North Carolina, United States
Carolinas Medical Center, Charlotte
🇺🇸Charlotte, North Carolina, United States
Wayne Memorial Hospital, Incorporated
🇺🇸Goldsboro, North Carolina, United States
Wilson Medical Center
🇺🇸Wilson, North Carolina, United States
Kinston Medical Specialists
🇺🇸Kinston, North Carolina, United States
Lenoir Memorial Hospital
🇺🇸Kinston, North 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-Eastside
🇺🇸Greenville, South Carolina, United States
Greenville Health System Cancer Institute-Faris
🇺🇸Greenville, South Carolina, United States
Greenville Memorial Hospital
🇺🇸Greenville, South Carolina, United States
Cancer Centers of the Carolinas-Green Medial Oncology
🇺🇸Greer, South Carolina, United States
Self Regional Healthcare
🇺🇸Greenwood, South Carolina, United States
Greenville Health System Cancer Institute-Spartanburg
🇺🇸Spartanburg, South Carolina, United States
Greenville Health System Cancer Institute-Seneca
🇺🇸Seneca, South Carolina, United States
Baptist Memorial Hospital and Cancer Center-Memphis
🇺🇸Memphis, Tennessee, United States
Central Vermont Medical Center/ National Life Cancer Treatment
🇺🇸Berlin, Vermont, United States
University of Vermont College of Medicine
🇺🇸Burlington, Vermont, United States
Northeastern
🇺🇸Saint Johnsbury, Vermont, United States
North Country Health
🇺🇸Newport, Vermont, United States
Springfield Hospital
🇺🇸Springfield, Vermont, United States
Danville Regional Medical Center
🇺🇸Danville, Virginia, United States
SUNY Upstate Medical University Hospital
🇺🇸Syracuse, New York, United States
University of Missouri - Ellis Fischel,
🇺🇸Columbia, Missouri, United States
Mission Hospital-Memorial Campus
🇺🇸Asheville, North Carolina, United States
Veterans Administration
🇺🇸Columbia, Missouri, United States
Saint Joseph's Hospital Health Center
🇺🇸Syracuse, New York, United States
Veterans Affairs Medical Center - Syracuse
🇺🇸Syracuse, New York, United States
Mission Hospital-Saint Joseph Campus
🇺🇸Asheville, North Carolina, United States
Dartmouth Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Wake Forest University Comprehensive Cancer Center
🇺🇸Winston-Salem, North Carolina, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
University of North Carolina
🇺🇸Chapel Hill, North Carolina, United States
Cheshire Medical Center-Dartmouth-Hitchcock Keene
🇺🇸Keene, New Hampshire, United States
Illinois CancerCare-Community Cancer Center
🇺🇸Normal, Illinois, United States
Pekin Cancer Treatment Center
🇺🇸Pekin, Illinois, United States
Ottwa Regional Hospital and Healthcare
🇺🇸Ottawa, Illinois, United States
Illinois CancerCare- Pekin
🇺🇸Pekin, Illinois, United States
Illinois CancerCare-Kewanee Clinic
🇺🇸Kewanee, Illinois, United States