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NCT01004640 Clinical Trial

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

Leukemia Clinical Trial

Official title:
Molecular and Cytogenetic Monitoring of CML - A Mandatory Companion to CALGB 19804

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT01004640
Other study ID # CALGB-29801
Secondary ID U10CA031946U10CA
Status Active, not recruiting
Phase
First received
Last updated
Start date December 15, 1998

Study information
Verified date September 2023
Source Alliance for Clinical Trials in Oncology
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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 information / eligibility
Status Active, not recruiting
Enrollment 60
Est. completion date
Est. primary completion date February 2001
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Genetic:
• DNA analysis

• Southern blotting

• cytogenetic analysis
Correlative studies
• polymerase chain reaction

Locations
Country Name City State
United States Mission Hospital-Memorial Campus Asheville North Carolina
United States Mission Hospital-Saint Joseph Campus Asheville North Carolina
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 CancerCare of Maine at Eastern Maine Medical Center Bangor Maine
United States Eastern Maine Medical Center, Bangor Bangor Maine
United States Central Vermont Medical Center/ National Life Cancer Treatment Berlin Vermont
United States Illinois CancerCare-Bloomington Bloomington Illinois
United States Saint Joseph Medical Center Bloomington Illinois
United States Beth Israel Deaconess Medical Center Boston Massachusetts
United States Brigham and Women's Hospital Boston Massachusetts
United States Dana-Farber Cancer Institute Boston Massachusetts
United States Massachusetts General Hospital Boston Massachusetts
United States Roswell Park Cancer Institute Buffalo New York
United States Fletcher Allen Health Care - University Health Center Campus Burlington Vermont
United States University of Vermont College of Medicine Burlington Vermont
United States Cooper Hospital University Medical Center Camden New Jersey
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 Mercy Hospital Cedar Rapids Iowa
United States Physicians' Clinic of Iowa PC Cedar Rapids Iowa
United States Saint Luke's Hospital Cedar Rapids Iowa
United States University of North Carolina Chapel Hill North Carolina
United States Medical University of South Carolina Charleston South Carolina
United States Carolinas Medical Center, Charlotte Charlotte North Carolina
United States Novant Health Presbyterian Medical Center Charlotte North Carolina
United States Jesse Brown Veterans Affairs Medical Center Chicago Illinois
United States Mount Sinai Hospital Medical Center Chicago Illinois
United States University of Chicago Cancer Research Center Chicago Illinois
United States University of Illinois Cancer Center Chicago Illinois
United States Weiss Memorial Hospital Chicago Illinois
United States Valley Regional Claremont New Hampshire
United States Ellis Fischel Cancer Center at University of Missouri - Columbia Columbia Missouri
United States Missouri Cancer Associates Columbia Missouri
United States University of Missouri - Ellis Fischel, Columbia Missouri
United States Veterans Administration Columbia Missouri
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 Danville Regional Medical Center Danville Virginia
United States Duke University Medical Center Durham North Carolina
United States Greenville Health System Cancer Institute-Easley Easley South Carolina
United States CCOP - Hematology-Oncology Associates of Central New York East Syracuse New York
United States Elkhart General Hospital Elkhart Indiana
United States Union Hospital Cancer Program at Union Hospital Elkton Maryland
United States Elmhurst Hospital Center Elmhurst New York
United States Eureka Hospital Eureka Illinois
United States Illinois CancerCare-Eureka Eureka Illinois
United States Broward Health Medical Center Fort Lauderdale Florida
United States Holy Cross Hospital Fort Lauderdale Florida
United States Fort Wayne Medical Oncology and Hematology Fort Wayne Indiana
United States Galesburg Cottage Hospital Galesburg Illinois
United States Illinois CancerCare Galesburg Galesburg Illinois
United States Illinois CancerCare-Cottage Galesburg Illinois
United States Western Illinois Cancer Treatment Center Galesburg Illinois
United States Glens Falls Hospital Glens Falls New York
United States Wayne Memorial Hospital, Incorporated Goldsboro North Carolina
United States Illinois Oncology Limited Granite City Illinois
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 Saint Francis Hospital 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 Illinois CancerCare-Havana Havana Illinois
United States Mason District Hospital Havana Illinois
United States Memorial Healthcare System - Joe DiMaggio Children's Hospital Hollywood Florida
United States Hopedale Medical Complex - Hospital, Hopedale Hopedale Illinois
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 Queens Hospital Center Jamaica New York
United States Capital Regional Medical Center Jefferson City Missouri
United States Jupiter Medical Center Jupiter Florida
United States Cheshire Medical Center-Dartmouth-Hitchcock Keene Keene New Hampshire
United States Illinois CancerCare-Kewanee Clinic Kewanee Illinois
United States Kewanee Hospital Kewanee Illinois
United States Kinston Medical Specialists Kinston North Carolina
United States Lenoir Memorial Hospital Kinston North Carolina
United States Community Howard Regional Health Kokomo Indiana
United States IU Health La Porte Hospital La Porte Indiana
United States Weeks Memorial Hospital Lancaster New Hampshire
United States CCOP - Nevada Cancer Research Foundation Las Vegas Nevada
United States Nevada Cancer Research Foundation CCOP Las Vegas Nevada
United States University Medical Center of Southern Nevada Las Vegas Nevada
United States Alice Peck Day Memorial Hospital Lebanon New Hampshire
United States Dartmouth Hitchcock Medical Center Lebanon New Hampshire
United States Beebe Medical Center Lewes Delaware
United States Saint Barnabas Medical Center Livingston New Jersey
United States Illinois CancerCare-Macomb Macomb Illinois
United States Mcdonough District Hospital Macomb Illinois
United States Baptist Memorial Hospital and Cancer Center-Memphis Memphis Tennessee
United States Mount Sinai Medical Center Miami Beach Florida
United States Saint Joseph Regional Medical Center - Mishawaka Mishawaka Indiana
United States Holy Family Medical Center Monmouth Illinois
United States Illinois CancerCare-Monmouth Monmouth Illinois
United States Memorial Sloan-Kettering Cancer Center New York New York
United States Mount Sinai Medical Center New York New York
United States Weill Medical College of Cornell University New York New York
United States Christiana Care Health Services Newark Delaware
United States North Country Health Newport Vermont
United States Bromenn Regional Medical Center Normal Illinois
United States Community Cancer Center Foundation Normal Illinois
United States Illinois CancerCare-Community Cancer Center Normal Illinois
United States Oswego Hospital Oswego New York
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 Illinois CancerCare- Peoria Peoria Illinois
United States Illinois Oncology Research Association-CCOP Peoria Illinois
United States Methodist Medical Center of Illinois Peoria Illinois
United States OSF Saint Francis Medical Center Peoria Illinois
United States Proctor Hospital 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 West Penn Hospital Pittsburgh Pennsylvania
United States Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital Pittsburgh Pennsylvania
United States Illinois CancerCare- Princeton Princeton Illinois
United States Perry Memorial Hospital Princeton Illinois
United States Frisbie Hospital Rochester New Hampshire
United States Sarah Culberston Memorial Hospital Rushville Illinois
United States Northeastern Saint Johnsbury Vermont
United States Lakeland Hospital Saint Joseph Missouri
United States Oncology Care Associates PLLC Saint Joseph Michigan
United States Arch Medical Services, Incorporated at Center for Cancer Care and Research Saint Louis Missouri
United States Center for Cancer Care and Research Saint Louis Missouri
United States Comprehensive Cancer Care, PC Saint Louis Missouri
United States Missouri Baptist Cancer Center Saint Louis Missouri
United States Missouri Baptist Medical Center Saint Louis Missouri
United States Washington University School of Medicine Saint Louis Missouri
United States Naval Medical Center - San Diego San Diego California
United States UCSF Medical Center-Mount Zion San Francisco California
United States Nanticoke Memorial Hospital Seaford Delaware
United States Greenville Health System Cancer Institute-Seneca Seneca South Carolina
United States Memorial Hospital of South Bend South Bend Indiana
United States Northern Indiana Cancer Research Consrtium South Bend Indiana
United States Greenville Health System Cancer Institute-Spartanburg Spartanburg South Carolina
United States Illinois CancerCare- Spring Valley Spring Valley Illinois
United States Saint Margaret's Hospital Spring Valley Illinois
United States Springfield Hospital Springfield Vermont
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 Cancer Institute of New Jersey at Cooper - Voorhees Voorhees New Jersey
United States Lombardi Comprehensive Cancer Center at Georgetown University Medical Center Washington District of Columbia
United States Washington Hospital Center Washington District of Columbia
United States White River Junction Veteran Administration Medical Center White River Junction Vermont
United States Saint Francis Hospital - Wilmington Wilmington Delaware
United States Wilson Medical Center Wilson North Carolina
United States Wake Forest University Comprehensive Cancer Center Winston-Salem North Carolina
United States Commonwealth Hematology Oncology PC-Worcester, Worcester Worcester Massachusetts
United States University of Massachusetts Medical School Worcester Massachusetts

Sponsors (2)
Lead Sponsor Collaborator
Alliance for Clinical Trials in Oncology National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Distribution response Up to 1.5 years
Primary Distribution of cytogenetic response Up to 1.5 years
Primary Distribution of RT-PCR response or Southern blot response Up to 1.5 years
Primary Frequency of residual disease in patients who have achieved a complete response Up to 12 months
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