Study of Blood and Bone Marrow Samples in Patients With Chronic Myelogenous Leukemia Enrolled on a CALGB Clinical Trial
Sponsor
Alliance for Clinical Trials in Oncology (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT01004640
Collaborator
National Cancer Institute (NCI) (NIH)
60
161
0.4
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Study Type:
Observational
Anticipated Enrollment
:
60 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Molecular and Cytogenetic Monitoring of CML - A Mandatory Companion to CALGB 19804
Actual Study Start Date
:
Dec 15, 1998
Actual Primary Completion Date
:
Feb 1, 2001
Arms and Interventions
| Arm | 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: Southern blotting
Genetic: cytogenetic analysis
Correlative studies
Other Names:
Genetic: polymerase chain reaction
|
Outcome Measures
Primary Outcome Measures
- 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]
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Naval Medical Center - San Diego | San Diego | California | United States | 92134 |
| 2 | UCSF Medical Center-Mount Zion | San Francisco | California | United States | 94115 |
| 3 | Beebe Medical Center | Lewes | Delaware | United States | 19958 |
| 4 | Christiana Care Health Services | Newark | Delaware | United States | 19718 |
| 5 | Nanticoke Memorial Hospital | Seaford | Delaware | United States | 19973 |
| 6 | Saint Francis Hospital - Wilmington | Wilmington | Delaware | United States | 19805 |
| 7 | Washington Hospital Center | Washington | District of Columbia | United States | 20010 |
| 8 | Lombardi Comprehensive Cancer Center at Georgetown University Medical Center | Washington | District of Columbia | United States | 20057 |
| 9 | Holy Cross Hospital | Fort Lauderdale | Florida | United States | 33308 |
| 10 | Broward Health Medical Center | Fort Lauderdale | Florida | United States | 33316 |
| 11 | Memorial Healthcare System - Joe DiMaggio Children's Hospital | Hollywood | Florida | United States | 33021 |
| 12 | Jupiter Medical Center | Jupiter | Florida | United States | 33548 |
| 13 | Mount Sinai Medical Center | Miami Beach | Florida | United States | 33140 |
| 14 | Illinois CancerCare-Bloomington | Bloomington | Illinois | United States | 61701 |
| 15 | Saint Joseph Medical Center | Bloomington | Illinois | United States | 61701 |
| 16 | Graham Hospital Assocation | Canton | Illinois | United States | 29605 |
| 17 | Illinois CancerCare-Canton | Canton | Illinois | United States | 61520 |
| 18 | Illinois CancerCare-Carthage | Carthage | Illinois | United States | 62321 |
| 19 | Memorial Hospital | Carthage | Illinois | United States | 62321 |
| 20 | Mount Sinai Hospital Medical Center | Chicago | Illinois | United States | 60608 |
| 21 | University of Illinois Cancer Center | Chicago | Illinois | United States | 60612-7243 |
| 22 | Jesse Brown Veterans Affairs Medical Center | Chicago | Illinois | United States | 60612 |
| 23 | University of Chicago Cancer Research Center | Chicago | Illinois | United States | 60637-1470 |
| 24 | Weiss Memorial Hospital | Chicago | Illinois | United States | 60640 |
| 25 | Eureka Hospital | Eureka | Illinois | United States | 61530 |
| 26 | Illinois CancerCare-Eureka | Eureka | Illinois | United States | 615330 |
| 27 | Galesburg Cottage Hospital | Galesburg | Illinois | United States | 61401 |
| 28 | Illinois CancerCare Galesburg | Galesburg | Illinois | United States | 61401 |
| 29 | Western Illinois Cancer Treatment Center | Galesburg | Illinois | United States | 61401 |
| 30 | Illinois CancerCare-Cottage | Galesburg | Illinois | United States | 61761 |
| 31 | Illinois Oncology Limited | Granite City | Illinois | United States | 62040 |
| 32 | Illinois CancerCare-Havana | Havana | Illinois | United States | 62644 |
| 33 | Mason District Hospital | Havana | Illinois | United States | 62644 |
| 34 | Hopedale Medical Complex - Hospital, Hopedale | Hopedale | Illinois | United States | 61847 |
| 35 | Illinois CancerCare-Kewanee Clinic | Kewanee | Illinois | United States | 61443 |
| 36 | Kewanee Hospital | Kewanee | Illinois | United States | 61443 |
| 37 | Illinois CancerCare-Macomb | Macomb | Illinois | United States | 61455 |
| 38 | Mcdonough District Hospital | Macomb | Illinois | United States | 61455 |
| 39 | Holy Family Medical Center | Monmouth | Illinois | United States | 61462 |
| 40 | Illinois CancerCare-Monmouth | Monmouth | Illinois | United States | 61462 |
| 41 | Community Cancer Center Foundation | Normal | Illinois | United States | 61761 |
| 42 | Illinois CancerCare-Community Cancer Center | Normal | Illinois | United States | 61761 |
| 43 | Bromenn Regional Medical Center | Normal | Illinois | United States | 61861 |
| 44 | Illinois CancerCare- Ottawa Clinic | Ottawa | Illinois | United States | 61350 |
| 45 | Ottwa Regional Hospital and Healthcare | Ottawa | Illinois | United States | 61350 |
| 46 | Illinois CancerCare- Pekin | Pekin | Illinois | United States | 61554 |
| 47 | Pekin Cancer Treatment Center | Pekin | Illinois | United States | 61554 |
| 48 | Pekin Hospital | Pekin | Illinois | United States | 61554 |
| 49 | Methodist Medical Center of Illinois | Peoria | Illinois | United States | 61603 |
| 50 | Proctor Hospital | Peoria | Illinois | United States | 61614 |
| 51 | Illinois CancerCare- Peoria | Peoria | Illinois | United States | 61615 |
| 52 | Illinois Oncology Research Association-CCOP | Peoria | Illinois | United States | 61615 |
| 53 | OSF Saint Francis Medical Center | Peoria | Illinois | United States | 61637 |
| 54 | Illinois CancerCare- Peru | Peru | Illinois | United States | 61354 |
| 55 | Illinois Valley Hospital | Peru | Illinois | United States | 61354 |
| 56 | Valley Radiation Oncology | Peru | Illinois | United States | 61354 |
| 57 | Illinois CancerCare- Princeton | Princeton | Illinois | United States | 61356 |
| 58 | Perry Memorial Hospital | Princeton | Illinois | United States | 61356 |
| 59 | Sarah Culberston Memorial Hospital | Rushville | Illinois | United States | 62681 |
| 60 | Illinois CancerCare- Spring Valley | Spring Valley | Illinois | United States | 61362 |
| 61 | Saint Margaret's Hospital | Spring Valley | Illinois | United States | 61362 |
| 62 | Elkhart General Hospital | Elkhart | Indiana | United States | 46515 |
| 63 | Fort Wayne Medical Oncology and Hematology | Fort Wayne | Indiana | United States | 46845 |
| 64 | Community Howard Regional Health | Kokomo | Indiana | United States | 46904 |
| 65 | IU Health La Porte Hospital | La Porte | Indiana | United States | 46350 |
| 66 | Saint Joseph Regional Medical Center - Mishawaka | Mishawaka | Indiana | United States | 46545-1470 |
| 67 | Memorial Hospital of South Bend | South Bend | Indiana | United States | 46601 |
| 68 | Northern Indiana Cancer Research Consrtium | South Bend | Indiana | United States | 46628 |
| 69 | Physicians' Clinic of Iowa PC | Cedar Rapids | Iowa | United States | 52402 |
| 70 | Mercy Hospital | Cedar Rapids | Iowa | United States | 52403 |
| 71 | Saint Luke's Hospital | Cedar Rapids | Iowa | United States | 54202 |
| 72 | Holden Comprehensive Cancer Center at University of Iowa | Iowa City | Iowa | United States | 52242-1002 |
| 73 | University of Iowa Hospitals and Clinics | Iowa City | Iowa | United States | 52242 |
| 74 | CancerCare of Maine at Eastern Maine Medical Center | Bangor | Maine | United States | 04401 |
| 75 | Eastern Maine Medical Center, Bangor | Bangor | Maine | United States | 04401 |
| 76 | Greenebaum Cancer Center at University of Maryland Medical Center | Baltimore | Maryland | United States | 21201 |
| 77 | University of Maryland/Greenebaum Cancer Center | Baltimore | Maryland | United States | 21201 |
| 78 | Union Hospital Cancer Program at Union Hospital | Elkton | Maryland | United States | 21921 |
| 79 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02114 |
| 80 | Brigham and Women's Hospital | Boston | Massachusetts | United States | 02115 |
| 81 | Dana-Farber Cancer Institute | Boston | Massachusetts | United States | 02115 |
| 82 | Beth Israel Deaconess Medical Center | Boston | Massachusetts | United States | 02215 |
| 83 | Commonwealth Hematology Oncology PC-Worcester, Worcester | Worcester | Massachusetts | United States | 01605 |
| 84 | University of Massachusetts Medical School | Worcester | Massachusetts | United States | 01655 |
| 85 | Oncology Care Associates PLLC | Saint Joseph | Michigan | United States | 49085 |
| 86 | Missouri Cancer Associates | Columbia | Missouri | United States | 65201 |
| 87 | Veterans Administration | Columbia | Missouri | United States | 65201 |
| 88 | Ellis Fischel Cancer Center at University of Missouri - Columbia | Columbia | Missouri | United States | 65203 |
| 89 | University of Missouri - Ellis Fischel, | Columbia | Missouri | United States | 65212 |
| 90 | Capital Regional Medical Center | Jefferson City | Missouri | United States | 65101 |
| 91 | Lakeland Hospital | Saint Joseph | Missouri | United States | 49085 |
| 92 | Washington University School of Medicine | Saint Louis | Missouri | United States | 63110 |
| 93 | Missouri Baptist Cancer Center | Saint Louis | Missouri | United States | 63131 |
| 94 | Missouri Baptist Medical Center | Saint Louis | Missouri | United States | 63131 |
| 95 | Arch Medical Services, Incorporated at Center for Cancer Care and Research | Saint Louis | Missouri | United States | 63141 |
| 96 | Center for Cancer Care and Research | Saint Louis | Missouri | United States | 63141 |
| 97 | Comprehensive Cancer Care, PC | Saint Louis | Missouri | United States | 63141 |
| 98 | University Medical Center of Southern Nevada | Las Vegas | Nevada | United States | 89102 |
| 99 | CCOP - Nevada Cancer Research Foundation | Las Vegas | Nevada | United States | 89106 |
| 100 | Nevada Cancer Research Foundation CCOP | Las Vegas | Nevada | United States | 89106 |
| 101 | Valley Regional | Claremont | New Hampshire | United States | 03743 |
| 102 | Cheshire Medical Center-Dartmouth-Hitchcock Keene | Keene | New Hampshire | United States | 03431 |
| 103 | Weeks Memorial Hospital | Lancaster | New Hampshire | United States | 03584 |
| 104 | Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | United States | 03756 |
| 105 | Alice Peck Day Memorial Hospital | Lebanon | New Hampshire | United States | 03766 |
| 106 | Frisbie Hospital | Rochester | New Hampshire | United States | 03867 |
| 107 | Cooper Hospital University Medical Center | Camden | New Jersey | United States | 08103 |
| 108 | Saint Barnabas Medical Center | Livingston | New Jersey | United States | 07039 |
| 109 | Cancer Institute of New Jersey at Cooper - Voorhees | Voorhees | New Jersey | United States | 08043 |
| 110 | Roswell Park Cancer Institute | Buffalo | New York | United States | 14263 |
| 111 | CCOP - Hematology-Oncology Associates of Central New York | East Syracuse | New York | United States | 13057 |
| 112 | Elmhurst Hospital Center | Elmhurst | New York | United States | 11373 |
| 113 | Glens Falls Hospital | Glens Falls | New York | United States | 12801 |
| 114 | Queens Hospital Center | Jamaica | New York | United States | 11432 |
| 115 | Mount Sinai Medical Center | New York | New York | United States | 10029 |
| 116 | Memorial Sloan-Kettering Cancer Center | New York | New York | United States | 10065 |
| 117 | Weill Medical College of Cornell University | New York | New York | United States | 10065 |
| 118 | Oswego Hospital | Oswego | New York | United States | 13126 |
| 119 | Stony Brook University Medical Center | Stony Brook | New York | United States | 11794 |
| 120 | Hematology Oncology Associates of Central New York-East Syracuse | Syracuse | New York | United States | 13057 |
| 121 | Saint Joseph's Hospital Health Center | Syracuse | New York | United States | 13203 |
| 122 | State University of New York Upstate Medical University | Syracuse | New York | United States | 13210 |
| 123 | SUNY Upstate Medical University Hospital | Syracuse | New York | United States | 13210 |
| 124 | Syracuse Veterans Administration Medical Center | Syracuse | New York | United States | 13210 |
| 125 | Veterans Affairs Medical Center - Syracuse | Syracuse | New York | United States | 13210 |
| 126 | Mission Hospital-Memorial Campus | Asheville | North Carolina | United States | 28801 |
| 127 | Mission Hospital-Saint Joseph Campus | Asheville | North Carolina | United States | 28801 |
| 128 | University of North Carolina | Chapel Hill | North Carolina | United States | 27599 |
| 129 | Carolinas Medical Center, Charlotte | Charlotte | North Carolina | United States | 28203 |
| 130 | Novant Health Presbyterian Medical Center | Charlotte | North Carolina | United States | 28204 |
| 131 | Duke University Medical Center | Durham | North Carolina | United States | 27710 |
| 132 | Wayne Memorial Hospital, Incorporated | Goldsboro | North Carolina | United States | 27534 |
| 133 | Kinston Medical Specialists | Kinston | North Carolina | United States | 28501 |
| 134 | Lenoir Memorial Hospital | Kinston | North Carolina | United States | 28501 |
| 135 | Wilson Medical Center | Wilson | North Carolina | United States | 27893 |
| 136 | Wake Forest University Comprehensive Cancer Center | Winston-Salem | North Carolina | United States | 27157-1096 |
| 137 | Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | Columbus | Ohio | United States | 43210 |
| 138 | Ohio State University Comprehensive Cancer Center | Columbus | Ohio | United States | 43210 |
| 139 | Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital | Pittsburgh | Pennsylvania | United States | 15224-1791 |
| 140 | West Penn Hospital | Pittsburgh | Pennsylvania | United States | 15224 |
| 141 | Medical University of South Carolina | Charleston | South Carolina | United States | 29425 |
| 142 | Greenville Health System Cancer Institute-Easley | Easley | South Carolina | United States | 29640 |
| 143 | Saint Francis Hospital | Greenville | South Carolina | United States | 29601 |
| 144 | Greenville Health System Cancer Institute-Andrews | Greenville | South Carolina | United States | 29605 |
| 145 | Greenville Health System Cancer Institute-Butternut | Greenville | South Carolina | United States | 29605 |
| 146 | Greenville Health System Cancer Institute-Faris | Greenville | South Carolina | United States | 29605 |
| 147 | Greenville Memorial Hospital | Greenville | South Carolina | United States | 29605 |
| 148 | Greenville Health System Cancer Institute-Eastside | Greenville | South Carolina | United States | 29615 |
| 149 | Self Regional Healthcare | Greenwood | South Carolina | United States | 29646 |
| 150 | Cancer Centers of the Carolinas-Green Medial Oncology | Greer | South Carolina | United States | 29650 |
| 151 | Greenville Health System Cancer Institute-Seneca | Seneca | South Carolina | United States | 29672 |
| 152 | Greenville Health System Cancer Institute-Spartanburg | Spartanburg | South Carolina | United States | 29307 |
| 153 | Baptist Memorial Hospital and Cancer Center-Memphis | Memphis | Tennessee | United States | 38120 |
| 154 | Central Vermont Medical Center/ National Life Cancer Treatment | Berlin | Vermont | United States | 05602 |
| 155 | Fletcher Allen Health Care - University Health Center Campus | Burlington | Vermont | United States | 05401 |
| 156 | University of Vermont College of Medicine | Burlington | Vermont | United States | 05405 |
| 157 | North Country Health | Newport | Vermont | United States | 05855 |
| 158 | Northeastern | Saint Johnsbury | Vermont | United States | 05819 |
| 159 | Springfield Hospital | Springfield | Vermont | United States | 05156 |
| 160 | White River Junction Veteran Administration Medical Center | White River Junction | Vermont | United States | 05009 |
| 161 | Danville Regional Medical Center | Danville | Virginia | United States | 24541 |
Sponsors and Collaborators
- Alliance for Clinical Trials in Oncology
- National Cancer Institute (NCI)
Investigators
- Study Chair: Wendy Stock, MD, University of Chicago
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT01004640
Other Study ID Numbers:
- CALGB-29801
- U10CA031946
- U10CA180821
- CDR0000078595
First Posted:
Oct 30, 2009
Last Update Posted:
Aug 3, 2022
Last Verified:
Aug 1, 2022
Keywords provided by Alliance for Clinical Trials in Oncology
Additional relevant MeSH terms: