NCT01004640

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Geographic Reach
1 country

161 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 15, 1998

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2001

Completed
8.7 years until next milestone

First Submitted

Initial submission to the registry

October 29, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 30, 2009

Completed
Last Updated

September 14, 2023

Status Verified

September 1, 2023

Enrollment Period

2.1 years

First QC Date

October 29, 2009

Last Update Submit

September 13, 2023

Conditions

Keywords

chronic myelogenous leukemia

Outcome Measures

Primary Outcomes (4)

  • Distribution response

    Up to 1.5 years

  • Distribution of cytogenetic response

    Up to 1.5 years

  • Distribution of RT-PCR response or Southern blot response

    Up to 1.5 years

  • Frequency of residual disease in patients who have achieved a complete response

    Up to 12 months

Study Arms (1)

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.

Genetic: DNA analysisGenetic: Southern blottingGenetic: cytogenetic analysisGenetic: polymerase chain reaction

Interventions

Group 1
Group 1

Correlative studies

Also known as: Laboratory Biomarker Analysis
Group 1

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

PATIENTS ENTERED ONTO CALGB TREATMENT STUDIES FOR CML

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (161)

Naval Medical Center - San Diego

San Diego, California, 92134, United States

Location

UCSF Medical Center-Mount Zion

San Francisco, California, 94115, United States

Location

Beebe Medical Center

Lewes, Delaware, 19958, United States

Location

Christiana Care Health Services

Newark, Delaware, 19718, United States

Location

Nanticoke Memorial Hospital

Seaford, Delaware, 19973, United States

Location

Saint Francis Hospital - Wilmington

Wilmington, Delaware, 19805, United States

Location

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Lombardi Comprehensive Cancer Center at Georgetown University Medical Center

Washington D.C., District of Columbia, 20057, United States

Location

Holy Cross Hospital

Fort Lauderdale, Florida, 33308, United States

Location

Broward Health Medical Center

Fort Lauderdale, Florida, 33316, United States

Location

Memorial Healthcare System - Joe DiMaggio Children's Hospital

Hollywood, Florida, 33021, United States

Location

Jupiter Medical Center

Jupiter, Florida, 33548, United States

Location

Mount Sinai Medical Center

Miami Beach, Florida, 33140, United States

Location

Illinois CancerCare-Bloomington

Bloomington, Illinois, 61701, United States

Location

Saint Joseph Medical Center

Bloomington, Illinois, 61701, United States

Location

Graham Hospital Assocation

Canton, Illinois, 29605, United States

Location

Illinois CancerCare-Canton

Canton, Illinois, 61520, United States

Location

Illinois CancerCare-Carthage

Carthage, Illinois, 62321, United States

Location

Memorial Hospital

Carthage, Illinois, 62321, United States

Location

Mount Sinai Hospital Medical Center

Chicago, Illinois, 60608, United States

Location

University of Illinois Cancer Center

Chicago, Illinois, 60612-7243, United States

Location

Jesse Brown Veterans Affairs Medical Center

Chicago, Illinois, 60612, United States

Location

University of Chicago Cancer Research Center

Chicago, Illinois, 60637-1470, United States

Location

Weiss Memorial Hospital

Chicago, Illinois, 60640, United States

Location

Eureka Hospital

Eureka, Illinois, 61530, United States

Location

Illinois CancerCare-Eureka

Eureka, Illinois, 615330, United States

Location

Galesburg Cottage Hospital

Galesburg, Illinois, 61401, United States

Location

Illinois CancerCare Galesburg

Galesburg, Illinois, 61401, United States

Location

Western Illinois Cancer Treatment Center

Galesburg, Illinois, 61401, United States

Location

Illinois CancerCare-Cottage

Galesburg, Illinois, 61761, United States

Location

Illinois Oncology Limited

Granite City, Illinois, 62040, United States

Location

Illinois CancerCare-Havana

Havana, Illinois, 62644, United States

Location

Mason District Hospital

Havana, Illinois, 62644, United States

Location

Hopedale Medical Complex - Hospital, Hopedale

Hopedale, Illinois, 61847, United States

Location

Illinois CancerCare-Kewanee Clinic

Kewanee, Illinois, 61443, United States

Location

Kewanee Hospital

Kewanee, Illinois, 61443, United States

Location

Illinois CancerCare-Macomb

Macomb, Illinois, 61455, United States

Location

Mcdonough District Hospital

Macomb, Illinois, 61455, United States

Location

Holy Family Medical Center

Monmouth, Illinois, 61462, United States

Location

Illinois CancerCare-Monmouth

Monmouth, Illinois, 61462, United States

Location

Community Cancer Center Foundation

Normal, Illinois, 61761, United States

Location

Illinois CancerCare-Community Cancer Center

Normal, Illinois, 61761, United States

Location

Bromenn Regional Medical Center

Normal, Illinois, 61861, United States

Location

Illinois CancerCare- Ottawa Clinic

Ottawa, Illinois, 61350, United States

Location

Ottwa Regional Hospital and Healthcare

Ottawa, Illinois, 61350, United States

Location

Illinois CancerCare- Pekin

Pekin, Illinois, 61554, United States

Location

Pekin Cancer Treatment Center

Pekin, Illinois, 61554, United States

Location

Pekin Hospital

Pekin, Illinois, 61554, United States

Location

Methodist Medical Center of Illinois

Peoria, Illinois, 61603, United States

Location

Proctor Hospital

Peoria, Illinois, 61614, United States

Location

Illinois CancerCare- Peoria

Peoria, Illinois, 61615, United States

Location

Illinois Oncology Research Association-CCOP

Peoria, Illinois, 61615, United States

Location

OSF Saint Francis Medical Center

Peoria, Illinois, 61637, United States

Location

Illinois CancerCare- Peru

Peru, Illinois, 61354, United States

Location

Illinois Valley Hospital

Peru, Illinois, 61354, United States

Location

Valley Radiation Oncology

Peru, Illinois, 61354, United States

Location

Illinois CancerCare- Princeton

Princeton, Illinois, 61356, United States

Location

Perry Memorial Hospital

Princeton, Illinois, 61356, United States

Location

Sarah Culberston Memorial Hospital

Rushville, Illinois, 62681, United States

Location

Illinois CancerCare- Spring Valley

Spring Valley, Illinois, 61362, United States

Location

Saint Margaret's Hospital

Spring Valley, Illinois, 61362, United States

Location

Elkhart General Hospital

Elkhart, Indiana, 46515, United States

Location

Fort Wayne Medical Oncology and Hematology

Fort Wayne, Indiana, 46845, United States

Location

Community Howard Regional Health

Kokomo, Indiana, 46904, United States

Location

IU Health La Porte Hospital

La Porte, Indiana, 46350, United States

Location

Saint Joseph Regional Medical Center - Mishawaka

Mishawaka, Indiana, 46545-1470, United States

Location

Memorial Hospital of South Bend

South Bend, Indiana, 46601, United States

Location

Northern Indiana Cancer Research Consrtium

South Bend, Indiana, 46628, United States

Location

Physicians' Clinic of Iowa PC

Cedar Rapids, Iowa, 52402, United States

Location

Mercy Hospital

Cedar Rapids, Iowa, 52403, United States

Location

Saint Luke's Hospital

Cedar Rapids, Iowa, 54202, United States

Location

Holden Comprehensive Cancer Center at University of Iowa

Iowa City, Iowa, 52242-1002, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

CancerCare of Maine at Eastern Maine Medical Center

Bangor, Maine, 04401, United States

Location

Eastern Maine Medical Center, Bangor

Bangor, Maine, 04401, United States

Location

Greenebaum Cancer Center at University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

University of Maryland/Greenebaum Cancer Center

Baltimore, Maryland, 21201, United States

Location

Union Hospital Cancer Program at Union Hospital

Elkton, Maryland, 21921, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Commonwealth Hematology Oncology PC-Worcester, Worcester

Worcester, Massachusetts, 01605, United States

Location

University of Massachusetts Medical School

Worcester, Massachusetts, 01655, United States

Location

Oncology Care Associates PLLC

Saint Joseph, Michigan, 49085, United States

Location

Missouri Cancer Associates

Columbia, Missouri, 65201, United States

Location

Veterans Administration

Columbia, Missouri, 65201, United States

Location

Ellis Fischel Cancer Center at University of Missouri - Columbia

Columbia, Missouri, 65203, United States

Location

University of Missouri - Ellis Fischel,

Columbia, Missouri, 65212, United States

Location

Capital Regional Medical Center

Jefferson City, Missouri, 65101, United States

Location

Lakeland Hospital

Saint Joseph, Missouri, 49085, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Missouri Baptist Cancer Center

St Louis, Missouri, 63131, United States

Location

Missouri Baptist Medical Center

St Louis, Missouri, 63131, United States

Location

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

St Louis, Missouri, 63141, United States

Location

Center for Cancer Care and Research

St Louis, Missouri, 63141, United States

Location

Comprehensive Cancer Care, PC

St Louis, Missouri, 63141, United States

Location

University Medical Center of Southern Nevada

Las Vegas, Nevada, 89102, United States

Location

CCOP - Nevada Cancer Research Foundation

Las Vegas, Nevada, 89106, United States

Location

Nevada Cancer Research Foundation CCOP

Las Vegas, Nevada, 89106, United States

Location

Valley Regional

Claremont, New Hampshire, 03743, United States

Location

Cheshire Medical Center-Dartmouth-Hitchcock Keene

Keene, New Hampshire, 03431, United States

Location

Weeks Memorial Hospital

Lancaster, New Hampshire, 03584, United States

Location

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Alice Peck Day Memorial Hospital

Lebanon, New Hampshire, 03766, United States

Location

Frisbie Hospital

Rochester, New Hampshire, 03867, United States

Location

Cooper Hospital University Medical Center

Camden, New Jersey, 08103, United States

Location

Saint Barnabas Medical Center

Livingston, New Jersey, 07039, United States

Location

Cancer Institute of New Jersey at Cooper - Voorhees

Voorhees Township, New Jersey, 08043, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

CCOP - Hematology-Oncology Associates of Central New York

East Syracuse, New York, 13057, United States

Location

Elmhurst Hospital Center

Elmhurst, New York, 11373, United States

Location

Glens Falls Hospital

Glens Falls, New York, 12801, United States

Location

Queens Hospital Center

Jamaica, New York, 11432, United States

Location

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

Weill Medical College of Cornell University

New York, New York, 10065, United States

Location

Oswego Hospital

Oswego, New York, 13126, United States

Location

Stony Brook University Medical Center

Stony Brook, New York, 11794, United States

Location

Hematology Oncology Associates of Central New York-East Syracuse

Syracuse, New York, 13057, United States

Location

Saint Joseph's Hospital Health Center

Syracuse, New York, 13203, United States

Location

State University of New York Upstate Medical University

Syracuse, New York, 13210, United States

Location

SUNY Upstate Medical University Hospital

Syracuse, New York, 13210, United States

Location

Syracuse Veterans Administration Medical Center

Syracuse, New York, 13210, United States

Location

Veterans Affairs Medical Center - Syracuse

Syracuse, New York, 13210, United States

Location

Mission Hospital-Memorial Campus

Asheville, North Carolina, 28801, United States

Location

Mission Hospital-Saint Joseph Campus

Asheville, North Carolina, 28801, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Carolinas Medical Center, Charlotte

Charlotte, North Carolina, 28203, United States

Location

Novant Health Presbyterian Medical Center

Charlotte, North Carolina, 28204, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Wayne Memorial Hospital, Incorporated

Goldsboro, North Carolina, 27534, United States

Location

Kinston Medical Specialists

Kinston, North Carolina, 28501, United States

Location

Lenoir Memorial Hospital

Kinston, North Carolina, 28501, United States

Location

Wilson Medical Center

Wilson, North Carolina, 27893, United States

Location

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157-1096, United States

Location

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

Columbus, Ohio, 43210, United States

Location

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital

Pittsburgh, Pennsylvania, 15224-1791, United States

Location

West Penn Hospital

Pittsburgh, Pennsylvania, 15224, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Greenville Health System Cancer Institute-Easley

Easley, South Carolina, 29640, United States

Location

Saint Francis Hospital

Greenville, South Carolina, 29601, United States

Location

Greenville Health System Cancer Institute-Andrews

Greenville, South Carolina, 29605, United States

Location

Greenville Health System Cancer Institute-Butternut

Greenville, South Carolina, 29605, United States

Location

Greenville Health System Cancer Institute-Faris

Greenville, South Carolina, 29605, United States

Location

Greenville Memorial Hospital

Greenville, South Carolina, 29605, United States

Location

Greenville Health System Cancer Institute-Eastside

Greenville, South Carolina, 29615, United States

Location

Self Regional Healthcare

Greenwood, South Carolina, 29646, United States

Location

Cancer Centers of the Carolinas-Green Medial Oncology

Greer, South Carolina, 29650, United States

Location

Greenville Health System Cancer Institute-Seneca

Seneca, South Carolina, 29672, United States

Location

Greenville Health System Cancer Institute-Spartanburg

Spartanburg, South Carolina, 29307, United States

Location

Baptist Memorial Hospital and Cancer Center-Memphis

Memphis, Tennessee, 38120, United States

Location

Central Vermont Medical Center/ National Life Cancer Treatment

Berlin Corners, Vermont, 05602, United States

Location

Fletcher Allen Health Care - University Health Center Campus

Burlington, Vermont, 05401, United States

Location

University of Vermont College of Medicine

Burlington, Vermont, 05405, United States

Location

North Country Health

Newport, Vermont, 05855, United States

Location

Northeastern

Saint Johnsbury, Vermont, 05819, United States

Location

Springfield Hospital

Springfield, Vermont, 05156, United States

Location

White River Junction Veteran Administration Medical Center

White River Junction, Vermont, 05009, United States

Location

Danville Regional Medical Center

Danville, Virginia, 24541, United States

Location

MeSH Terms

Conditions

LeukemiaLeukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

Blotting, SouthernCytogenetic AnalysisPolymerase Chain Reaction

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, MyeloidMyeloproliferative DisordersBone Marrow DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ElectrophoresisChemistry Techniques, AnalyticalInvestigative TechniquesElectrochemical TechniquesMolecular Probe TechniquesCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisGenetic TechniquesNucleic Acid Amplification Techniques

Study Officials

  • Wendy Stock, MD

    University of Chicago

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2009

First Posted

October 30, 2009

Study Start

December 15, 1998

Primary Completion

February 1, 2001

Last Updated

September 14, 2023

Record last verified: 2023-09

Locations