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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Leukemia
• Intervention / Treatment: Genetic: DNA analysis; Genetic: polymerase chain reaction; Genetic: cytogenetic analysis; Genetic: Southern blotting

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.

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92134
      • Naval Medical Center - San Diego
    • San Francisco, California, United States, 94115
      • UCSF Medical Center-Mount Zion
  • Delaware
    • Lewes, Delaware, United States, 19958
      • Beebe Medical Center
    • Newark, Delaware, United States, 19718
      • Christiana Care Health Services
    • Seaford, Delaware, United States, 19973
      • Nanticoke Memorial Hospital
    • Wilmington, Delaware, United States, 19805
      • Saint Francis Hospital - Wilmington
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Washington Hospital Center
    • Washington, District of Columbia, United States, 20057
      • Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
  • Florida
    • Fort Lauderdale, Florida, United States, 33316
      • Broward Health Medical Center
    • Fort Lauderdale, Florida, United States, 33308
      • Holy Cross Hospital
    • Hollywood, Florida, United States, 33021
      • Memorial Healthcare System - Joe DiMaggio Children's Hospital
    • Jupiter, Florida, United States, 33548
      • Jupiter Medical Center
    • Miami Beach, Florida, United States, 33140
      • Mount Sinai Medical Center
  • Illinois
    • Bloomington, Illinois, United States, 61701
      • Saint Joseph Medical Center
    • Bloomington, Illinois, United States, 61701
      • Illinois CancerCare-Bloomington
    • Canton, Illinois, United States, 61520
      • Illinois CancerCare-Canton
    • Canton, Illinois, United States, 29605
      • Graham Hospital Assocation
    • Carthage, Illinois, United States, 62321
      • Illinois CancerCare-Carthage
    • Carthage, Illinois, United States, 62321
      • Memorial Hospital
    • Chicago, Illinois, United States, 60637-1470
      • University of Chicago Cancer Research Center
    • Chicago, Illinois, United States, 60612-7243
      • University of Illinois Cancer Center
    • Chicago, Illinois, United States, 60608
      • Mount Sinai Hospital Medical Center
    • Chicago, Illinois, United States, 60640
      • Weiss Memorial Hospital
    • Chicago, Illinois, United States, 60612
      • Jesse Brown Veterans Affairs Medical Center
    • Eureka, Illinois, United States, 61530
      • Eureka Hospital
    • Eureka, Illinois, United States, 615330
      • Illinois CancerCare-Eureka
    • Galesburg, Illinois, United States, 61401
      • Western Illinois Cancer Treatment Center
    • Galesburg, Illinois, United States, 61401
      • Galesburg Cottage Hospital
    • Galesburg, Illinois, United States, 61401
      • Illinois CancerCare Galesburg
    • Galesburg, Illinois, United States, 61761
      • Illinois CancerCare-Cottage
    • Granite City, Illinois, United States, 62040
      • Illinois Oncology Limited
    • Havana, Illinois, United States, 62644
      • Mason District Hospital
    • Havana, Illinois, United States, 62644
      • Illinois CancerCare-Havana
    • Hopedale, Illinois, United States, 61847
      • Hopedale Medical Complex - Hospital, Hopedale
    • Kewanee, Illinois, United States, 61443
      • Illinois CancerCare-Kewanee Clinic
    • Kewanee, Illinois, United States, 61443
      • Kewanee Hospital
    • Macomb, Illinois, United States, 61455
      • Illinois CancerCare-Macomb
    • Macomb, Illinois, United States, 61455
      • Mcdonough District Hospital
    • Monmouth, Illinois, United States, 61462
      • Illinois CancerCare-Monmouth
    • Monmouth, Illinois, United States, 61462
      • Holy Family Medical Center
    • Normal, Illinois, United States, 61761
      • Community Cancer Center Foundation
    • Normal, Illinois, United States, 61761
      • Illinois CancerCare-Community Cancer Center
    • Normal, Illinois, United States, 61861
      • Bromenn Regional Medical Center
    • Ottawa, Illinois, United States, 61350
      • Illinois CancerCare- Ottawa Clinic
    • Ottawa, Illinois, United States, 61350
      • Ottwa Regional Hospital and Healthcare
    • Pekin, Illinois, United States, 61554
      • Pekin Cancer Treatment Center
    • Pekin, Illinois, United States, 61554
      • Pekin Hospital
    • Pekin, Illinois, United States, 61554
      • Illinois CancerCare- Pekin
    • Peoria, Illinois, United States, 61637
      • OSF Saint Francis Medical Center
    • Peoria, Illinois, United States, 61614
      • Proctor Hospital
    • Peoria, Illinois, United States, 61603
      • Methodist Medical Center of Illinois
    • Peoria, Illinois, United States, 61615
      • Illinois CancerCare- Peoria
    • Peoria, Illinois, United States, 61615
      • Illinois Oncology Research Association-CCOP
    • Peru, Illinois, United States, 61354
      • Valley Radiation Oncology
    • Peru, Illinois, United States, 61354
      • Illinois Valley Hospital
    • Peru, Illinois, United States, 61354
      • Illinois CancerCare- Peru
    • Princeton, Illinois, United States, 61356
      • Perry Memorial Hospital
    • Princeton, Illinois, United States, 61356
      • Illinois CancerCare- Princeton
    • Rushville, Illinois, United States, 62681
      • Sarah Culberston Memorial Hospital
    • Spring Valley, Illinois, United States, 61362
      • Saint Margaret's Hospital
    • Spring Valley, Illinois, United States, 61362
      • Illinois CancerCare- Spring Valley
  • Indiana
    • Elkhart, Indiana, United States, 46515
      • Elkhart General Hospital
    • Fort Wayne, Indiana, United States, 46845
      • Fort Wayne Medical Oncology and Hematology
    • Kokomo, Indiana, United States, 46904
      • Community Howard Regional Health
    • La Porte, Indiana, United States, 46350
      • IU Health La Porte Hospital
    • Mishawaka, Indiana, United States, 46545-1470
      • Saint Joseph Regional Medical Center - Mishawaka
    • South Bend, Indiana, United States, 46601
      • Memorial Hospital of South Bend
    • South Bend, Indiana, United States, 46628
      • Northern Indiana Cancer Research Consrtium
  • Iowa
    • Cedar Rapids, Iowa, United States, 52403
      • Mercy Hospital
    • Cedar Rapids, Iowa, United States, 52402
      • Physicians' Clinic of Iowa PC
    • Cedar Rapids, Iowa, United States, 54202
      • Saint Luke's Hospital
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals and Clinics
    • Iowa City, Iowa, United States, 52242-1002
      • Holden Comprehensive Cancer Center at University of Iowa
  • Maine
    • Bangor, Maine, United States, 04401
      • CancerCare of Maine at Eastern Maine Medical Center
    • Bangor, Maine, United States, 04401
      • Eastern Maine Medical Center, Bangor
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland/Greenebaum Cancer Center
    • Baltimore, Maryland, United States, 21201
      • Greenebaum Cancer Center at University of Maryland Medical Center
    • Elkton, Maryland, United States, 21921
      • Union Hospital Cancer Program at Union Hospital
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
    • Boston, Massachusetts, United States, 02115
      • Dana-Farber Cancer Institute
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Worcester, Massachusetts, United States, 01655
      • University of Massachusetts Medical School
    • Worcester, Massachusetts, United States, 01605
      • Commonwealth Hematology Oncology PC-Worcester, Worcester
  • Michigan
    • Saint Joseph, Michigan, United States, 49085
      • Oncology Care Associates PLLC
  • Missouri
    • Columbia, Missouri, United States, 65203
      • Ellis Fischel Cancer Center at University of Missouri - Columbia
    • Columbia, Missouri, United States, 65201
      • Missouri Cancer Associates
    • Columbia, Missouri, United States, 65201
      • Veterans Administration
    • Columbia, Missouri, United States, 65212
      • University of Missouri - Ellis Fischel,
    • Jefferson City, Missouri, United States, 65101
      • Capital Regional Medical Center
    • Saint Joseph, Missouri, United States, 49085
      • Lakeland Hospital
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine
    • Saint Louis, Missouri, United States, 63131
      • Missouri Baptist Cancer Center
    • Saint Louis, Missouri, United States, 63131
      • Missouri Baptist Medical Center
    • Saint Louis, Missouri, United States, 63141
      • Arch Medical Services, Incorporated at Center for Cancer Care and Research
    • Saint Louis, Missouri, United States, 63141
      • Center for Cancer Care and Research
    • Saint Louis, Missouri, United States, 63141
      • Comprehensive Cancer Care, PC
  • Nevada
    • Las Vegas, Nevada, United States, 89102
      • University Medical Center of Southern Nevada
    • Las Vegas, Nevada, United States, 89106
      • Nevada Cancer Research Foundation CCOP
    • Las Vegas, Nevada, United States, 89106
      • CCOP - Nevada Cancer Research Foundation
  • New Hampshire
    • Claremont, New Hampshire, United States, 03743
      • Valley Regional
    • Keene, New Hampshire, United States, 03431
      • Cheshire Medical Center-Dartmouth-Hitchcock Keene
    • Lancaster, New Hampshire, United States, 03584
      • Weeks Memorial Hospital
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth Hitchcock Medical Center
    • Lebanon, New Hampshire, United States, 03766
      • Alice Peck Day Memorial Hospital
    • Rochester, New Hampshire, United States, 03867
      • Frisbie Hospital
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • Cooper Hospital University Medical Center
    • Livingston, New Jersey, United States, 07039
      • Saint Barnabas Medical Center
    • Voorhees, New Jersey, United States, 08043
      • Cancer Institute of New Jersey at Cooper - Voorhees
  • New York
    • Buffalo, New York, United States, 14263
      • Roswell Park Cancer Institute
    • East Syracuse, New York, United States, 13057
      • CCOP - Hematology-Oncology Associates of Central New York
    • Elmhurst, New York, United States, 11373
      • Elmhurst Hospital Center
    • Glens Falls, New York, United States, 12801
      • Glens Falls Hospital
    • Jamaica, New York, United States, 11432
      • Queens Hospital Center
    • New York, New York, United States, 10065
      • Memorial Sloan-Kettering Cancer Center
    • New York, New York, United States, 10065
      • Weill Medical College of Cornell University
    • New York, New York, United States, 10029
      • Mount Sinai Medical Center
    • Oswego, New York, United States, 13126
      • Oswego Hospital
    • Stony Brook, New York, United States, 11794
      • Stony Brook University Medical Center
    • Syracuse, New York, United States, 13210
      • Veterans Affairs Medical Center - Syracuse
    • Syracuse, New York, United States, 13210
      • State University of New York Upstate Medical University
    • Syracuse, New York, United States, 13210
      • SUNY Upstate Medical University Hospital
    • Syracuse, New York, United States, 13210
      • Syracuse Veterans Administration Medical Center
    • Syracuse, New York, United States, 13203
      • Saint Joseph's Hospital Health Center
    • Syracuse, New York, United States, 13057
      • Hematology Oncology Associates of Central New York-East Syracuse
  • North Carolina
    • Asheville, North Carolina, United States, 28801
      • Mission Hospital-Memorial Campus
    • Asheville, North Carolina, United States, 28801
      • Mission Hospital-Saint Joseph Campus
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Novant Health Presbyterian Medical Center
    • Charlotte, North Carolina, United States, 28203
      • Carolinas Medical Center, Charlotte
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
    • Goldsboro, North Carolina, United States, 27534
      • Wayne Memorial Hospital, Incorporated
    • Kinston, North Carolina, United States, 28501
      • Kinston Medical Specialists
    • Kinston, North Carolina, United States, 28501
      • Lenoir Memorial Hospital
    • Wilson, North Carolina, United States, 27893
      • Wilson Medical Center
    • Winston-Salem, North Carolina, United States, 27157-1096
      • Wake Forest University Comprehensive Cancer Center
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University Comprehensive Cancer Center
    • Columbus, Ohio, United States, 43210
      • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15224
      • West Penn Hospital
    • Pittsburgh, Pennsylvania, United States, 15224-1791
      • Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
    • Easley, South Carolina, United States, 29640
      • Greenville Health System Cancer Institute-Easley
    • Greenville, South Carolina, United States, 29601
      • Saint Francis Hospital
    • Greenville, South Carolina, United States, 29605
      • Greenville Health System Cancer Institute-Andrews
    • Greenville, South Carolina, United States, 29605
      • Greenville Health System Cancer Institute-Faris
    • Greenville, South Carolina, United States, 29605
      • Greenville Memorial Hospital
    • Greenville, South Carolina, United States, 29615
      • Greenville Health System Cancer Institute-Eastside
    • Greenville, South Carolina, United States, 29605
      • Greenville Health System Cancer Institute-Butternut
    • Greenwood, South Carolina, United States, 29646
      • Self Regional Healthcare
    • Greer, South Carolina, United States, 29650
      • Cancer Centers of the Carolinas-Green Medial Oncology
    • Seneca, South Carolina, United States, 29672
      • Greenville Health System Cancer Institute-Seneca
    • Spartanburg, South Carolina, United States, 29307
      • Greenville Health System Cancer Institute-Spartanburg
  • Tennessee
    • Memphis, Tennessee, United States, 38120
      • Baptist Memorial Hospital and Cancer Center-Memphis
  • Vermont
    • Berlin, Vermont, United States, 05602
      • Central Vermont Medical Center/ National Life Cancer Treatment
    • Burlington, Vermont, United States, 05405
      • University of Vermont College of Medicine
    • Burlington, Vermont, United States, 05401
      • Fletcher Allen Health Care - University Health Center Campus
    • Newport, Vermont, United States, 05855
      • North Country Health
    • Saint Johnsbury, Vermont, United States, 05819
      • Northeastern
    • Springfield, Vermont, United States, 05156
      • Springfield Hospital
    • White River Junction, Vermont, United States, 05009
      • White River Junction Veteran Administration Medical Center
  • Virginia
    • Danville, Virginia, United States, 24541
      • Danville Regional Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

PATIENTS ENTERED ONTO CALGB TREATMENT STUDIES FOR CML

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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 analysis; Genetic: polymerase chain reaction; Genetic: cytogenetic analysis; Correlative studies; Other Names: Laboratory Biomarker Analysis; Genetic: Southern blotting

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Alliance for Clinical Trials in Oncology
• Collaborators: National Cancer Institute (NCI)
• Investigators: Study Chair: Wendy Stock, MD, University of Chicago

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 1998
• Primary Completion (Actual): February 1, 2001

Study Registration Dates

• First Submitted: October 29, 2009
• First Submitted That Met QC Criteria: October 29, 2009
• First Posted (Estimated): October 30, 2009

Study Record Updates

• Last Update Posted (Actual): September 14, 2023
• Last Update Submitted That Met QC Criteria: September 13, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: chronic myelogenous leukemia
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Leukemia
• Other Study ID Numbers: CALGB-29801; U10CA180821 (U.S. NIH Grant/Contract); U10CA031946 (U.S. NIH Grant/Contract); CDR0000078595 (Registry Identifier: NCI Physician Data Query)