Cytogenetic Studies in Acute Leukemia and Multiple Myeloma
Sponsor
Alliance for Clinical Trials in Oncology (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT00048958
Collaborator
National Cancer Institute (NCI) (NIH)
9,000
137
65.7
Study Details
Study Description
Brief Summary
Chromosomal analysis or the study of genetic differences in patients previously untreated with AML, ALL, MDS or MM may be helpful in the diagnosis and classification of disease. It may also improve the ability to predict the course of disease and the selection of therapy. Institutions must have either an Alliance-approved cytogeneticist or an agreement from an Alliance-approved main member cytogenetics laboratory to enroll a patient on CALGB 8461. The Alliance Approved Institutional Cytogeneticists list is posted on the Alliance for Clinical Trials in Oncology website.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Anticipated Enrollment
:
9000 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Cytogenetic Studies in Acute Leukemia and Multiple Myeloma: Companion to CALGB Treatment Studies For Previously Untreated Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL), Myelodysplastic Syndrome (MDS) or Multiple Myeloma (MM) Patients
Actual Study Start Date
:
Jun 1, 1984
Anticipated Primary Completion Date
:
Jan 1, 2100
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No treatment Samples as defined per the protocol for previously untreated patients with AML, ALL, MDS or MM will be submitted for analysis and within one month patients are required to register onto a CALGB treatment study. |
Genetic: cytogenetic analysis
|
Outcome Measures
Primary Outcome Measures
- Determine the incidence of specific less common primary as well as common secondary chromosome abnormalities in adult AML, ALL, MDS and MM [Up to 10 years]
- Correlate specific (normal or various primary and secondary chromosomal abnormalities) with clinical and laboratory parameters [Up to 10 years]
- Correlate specific karyotype groups with response rates, response duration, survival and cure in patients treated with various induction and post-induction regimens [Up to 10 years]
- Correlate specific karyotype groups with selected molecular abnormalities as studied in CALGB leukemia protocols [Up to 10 years]
- To correlate specific karyotype groups with multidrug resistance data [Up to 10 years]
- To correlate specific karyotype groups with epidemiologic data (toxic exposure and family history) [Up to 10 years]
- To determine karyotype changes at relapse and the influence of the type of change (or no change) in karyotype at relapse on subsequent clinical course [up to 10 yeras]
- To identify new chromosome abnormalities important in leukemogenesis [Up to 10 years]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
-
Patients from adjuncts are eligible if the Main Member Cytogenetics laboratory has agreed to process samples from that adjunct.
-
Within one month of registration on CALGB 8461, register onto a CALGB treatment study for previously untreated AML, ALL, MDS, or MM patients.
-
Simultaneously with registration on CALGB 8461, register patients within the continental United States onto CALGB 9665 (LTB).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Rebecca and John Moores UCSD Cancer Center | La Jolla | California | United States | 92093-0658 |
| 2 | Camino Medical Group - Treatment Center | Mountain View | California | United States | 94040 |
| 3 | Kaiser Permanente Medical Office -Vandever Medical Office | San Diego | California | United States | 92108 |
| 4 | Naval Medical Center - San Diego | San Diego | California | United States | 92134 |
| 5 | UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco | California | United States | 94115 |
| 6 | Tunnell Cancer Center at Beebe Medical Center | Lewes | Delaware | United States | 19958 |
| 7 | CCOP - Christiana Care Health Services | Newark | Delaware | United States | 19713 |
| 8 | Lombardi Comprehensive Cancer Center at Georgetown University Medical Center | Washington | District of Columbia | United States | 20007 |
| 9 | Washington Cancer Institute at Washington Hospital Center | Washington | District of Columbia | United States | 20010 |
| 10 | Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital | Fort Lauderdale | Florida | United States | 33308 |
| 11 | Ella Milbank Foshay Cancer Center at Jupiter Medical Center | Jupiter | Florida | United States | 33458 |
| 12 | CCOP - Mount Sinai Medical Center | Miami Beach | Florida | United States | 33140 |
| 13 | Illinois CancerCare - Bloomington | Bloomington | Illinois | United States | 61701 |
| 14 | St. Joseph Medical Center | Bloomington | Illinois | United States | 61701 |
| 15 | Graham Hospital | Canton | Illinois | United States | 61520 |
| 16 | Illinois CancerCare - Canton | Canton | Illinois | United States | 61520 |
| 17 | Illinois CancerCare - Carthage | Carthage | Illinois | United States | 62321 |
| 18 | Memorial Hospital | Carthage | Illinois | United States | 62321 |
| 19 | University of Illinois Cancer Center | Chicago | Illinois | United States | 60612-7243 |
| 20 | University of Chicago Cancer Research Center | Chicago | Illinois | United States | 60637-1470 |
| 21 | Eureka Community Hospital | Eureka | Illinois | United States | 61530 |
| 22 | Illinois CancerCare - Eureka | Eureka | Illinois | United States | 61530 |
| 23 | Evanston Hospital | Evanston | Illinois | United States | 60201-1781 |
| 24 | Galesburg Clinic, PC | Galesburg | Illinois | United States | 61401 |
| 25 | Illinois CancerCare - Galesburg | Galesburg | Illinois | United States | 61401 |
| 26 | Illinois CancerCare - Havana | Havana | Illinois | United States | 62644 |
| 27 | Mason District Hospital | Havana | Illinois | United States | 62644 |
| 28 | Illinois CancerCare - Kewanee Clinic | Kewanee | Illinois | United States | 61443 |
| 29 | Illinois CancerCare - Macomb | Macomb | Illinois | United States | 61455 |
| 30 | McDonough District Hospital | Macomb | Illinois | United States | 61455 |
| 31 | Illinois CancerCare - Monmouth | Monmouth | Illinois | United States | 61462 |
| 32 | OSF Holy Family Medical Center | Monmouth | Illinois | United States | 61462 |
| 33 | BroMenn Regional Medical Center | Normal | Illinois | United States | 61761 |
| 34 | Community Cancer Center | Normal | Illinois | United States | 61761 |
| 35 | Illinois CancerCare - Community Cancer Center | Normal | Illinois | United States | 61761 |
| 36 | Community Hospital of Ottawa | Ottawa | Illinois | United States | 61350 |
| 37 | Oncology Hematology Associates of Central Illinois, PC - Ottawa | Ottawa | Illinois | United States | 61350 |
| 38 | Cancer Treatment Center at Pekin Hospital | Pekin | Illinois | United States | 61554 |
| 39 | Illinois CancerCare - Pekin | Pekin | Illinois | United States | 61603 |
| 40 | Proctor Hospital | Peoria | Illinois | United States | 61614 |
| 41 | CCOP - Illinois Oncology Research Association | Peoria | Illinois | United States | 61615 |
| 42 | Oncology Hematology Associates of Central Illinois, PC - Peoria | Peoria | Illinois | United States | 61615 |
| 43 | Methodist Medical Center of Illinois | Peoria | Illinois | United States | 61636 |
| 44 | OSF St. Francis Medical Center | Peoria | Illinois | United States | 61637 |
| 45 | Illinois CancerCare - Peru | Peru | Illinois | United States | 61354 |
| 46 | Illinois Valley Community Hospital | Peru | Illinois | United States | 61354 |
| 47 | Illinois CancerCare - Princeton | Princeton | Illinois | United States | 61356 |
| 48 | Perry Memorial Hospital | Princeton | Illinois | United States | 61356 |
| 49 | Illinois CancerCare - Spring Valley | Spring Valley | Illinois | United States | 61362 |
| 50 | Fort Wayne Medical Oncology and Hematology | Fort Wayne | Indiana | United States | 46845 |
| 51 | Iowa Blood and Cancer Care | Cedar Rapids | Iowa | United States | 52402 |
| 52 | St. Luke's Hospital | Cedar Rapids | Iowa | United States | 52402 |
| 53 | Mercy Regional Cancer Center at Mercy Medical Center | Cedar Rapids | Iowa | United States | 52403 |
| 54 | Holden Comprehensive Cancer Center at University of Iowa | Iowa City | Iowa | United States | 52242-1002 |
| 55 | Menorah Medical Center | Overland Park | Kansas | United States | 66209 |
| 56 | Saint Luke's Hospital - South | Overland Park | Kansas | United States | 66213 |
| 57 | CCOP - Kansas City | Prairie Village | Kansas | United States | 66208 |
| 58 | Harold Alfond Center for Cancer Care | Augusta | Maine | United States | 04330 |
| 59 | CancerCare of Maine at Eastern Maine Medical Center | Bangor | Maine | United States | 04401 |
| 60 | Maine Center for Cancer Medicine and Blood Disorders - Scarborough | Scarborough | Maine | United States | 04074 |
| 61 | Greenebaum Cancer Center at University of Maryland Medical Center | Baltimore | Maryland | United States | 21201 |
| 62 | Harry and Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center | Baltimore | Maryland | United States | 21237 |
| 63 | Union Hospital of Cecil County | Elkton | Maryland | United States | 21921 |
| 64 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02114 |
| 65 | Dana-Farber/Brigham and Women's Cancer Center | Boston | Massachusetts | United States | 02115 |
| 66 | Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute | Boston | Massachusetts | United States | 02115 |
| 67 | Battle Creek Health System Cancer Care Center | Battle Creek | Michigan | United States | 49017 |
| 68 | Mecosta County Medical Center | Big Rapids | Michigan | United States | 49307 |
| 69 | Butterworth Hospital at Spectrum Health | Grand Rapids | Michigan | United States | 49503 |
| 70 | CCOP - Grand Rapids | Grand Rapids | Michigan | United States | 49503 |
| 71 | Lacks Cancer Center at Saint Mary's Health Care | Grand Rapids | Michigan | United States | 49503 |
| 72 | Mercy General Health Partners | Muskegon | Michigan | United States | 49444 |
| 73 | Spectrum Health Reed City Hospital | Reed City | Michigan | United States | 49677 |
| 74 | Munson Medical Center | Traverse City | Michigan | United States | 49684 |
| 75 | St. Luke's Hospital Cancer Care Center | Duluth | Minnesota | United States | 55805 |
| 76 | Veterans Affairs Medical Center - Minneapolis | Minneapolis | Minnesota | United States | 55417 |
| 77 | Masonic Cancer Center at University of Minnesota | Minneapolis | Minnesota | United States | 55455 |
| 78 | Southeast Cancer Center | Cape Girardeau | Missouri | United States | 63703 |
| 79 | Ellis Fischel Cancer Center at University of Missouri - Columbia | Columbia | Missouri | United States | 65203 |
| 80 | Goldschmidt Cancer Center | Jefferson City | Missouri | United States | 65109 |
| 81 | Saint Luke's Cancer Institute at Saint Luke's Hospital | Kansas City | Missouri | United States | 64111 |
| 82 | North Kansas City Hospital | Kansas City | Missouri | United States | 64116 |
| 83 | Heartland Hematology Oncology Associates, Incorporated | Kansas City | Missouri | United States | 64118 |
| 84 | Research Medical Center | Kansas City | Missouri | United States | 64132 |
| 85 | Saint Luke's East - Lee's Summit | Lee's Summit | Missouri | United States | 64086 |
| 86 | Parvin Radiation Oncology | Liberty | Missouri | United States | 64068 |
| 87 | Heartland Regional Medical Center | Saint Joseph | Missouri | United States | 64506 |
| 88 | Saint Joseph Oncology, Incorporated | Saint Joseph | Missouri | United States | 64507 |
| 89 | Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | Saint Louis | Missouri | United States | 63110 |
| 90 | Missouri Baptist Cancer Center | Saint Louis | Missouri | United States | 63131 |
| 91 | Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center | Grand Island | Nebraska | United States | 68803 |
| 92 | Callahan Cancer Center at Great Plains Regional Medical Center | North Platte | Nebraska | United States | 69103 |
| 93 | UNMC Eppley Cancer Center at the University of Nebraska Medical Center | Omaha | Nebraska | United States | 68198-6805 |
| 94 | University Medical Center of Southern Nevada | Las Vegas | Nevada | United States | 89102 |
| 95 | CCOP - Nevada Cancer Research Foundation | Las Vegas | Nevada | United States | 89106 |
| 96 | Sunrise Hospital and Medical Center | Las Vegas | Nevada | United States | 89109 |
| 97 | Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | United States | 03756-0002 |
| 98 | Cancer Institute of New Jersey at Cooper - Voorhees | Voorhees | New Jersey | United States | 08043 |
| 99 | Roswell Park Cancer Institute | Buffalo | New York | United States | 14263-0001 |
| 100 | CCOP - Hematology-Oncology Associates of Central New York | East Syracuse | New York | United States | 13057 |
| 101 | Charles R. Wood Cancer Center at Glens Falls Hospital | Glens Falls | New York | United States | 12801 |
| 102 | Monter Cancer Center of the North Shore-LIJ Health System | Lake Success | New York | United States | 11042 |
| 103 | CCOP - North Shore University Hospital | Manhasset | New York | United States | 11030 |
| 104 | Don Monti Comprehensive Cancer Center at North Shore University Hospital | Manhasset | New York | United States | 11030 |
| 105 | Long Island Jewish Medical Center | New Hyde Park | New York | United States | 11040 |
| 106 | New York Weill Cornell Cancer Center at Cornell University | New York | New York | United States | 10021 |
| 107 | Mount Sinai Medical Center | New York | New York | United States | 10029 |
| 108 | SUNY Upstate Medical University Hospital | Syracuse | New York | United States | 13210 |
| 109 | Mission Hospitals - Memorial Campus | Asheville | North Carolina | United States | 28801 |
| 110 | Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill | North Carolina | United States | 27599-7295 |
| 111 | Presbyterian Cancer Center at Presbyterian Hospital | Charlotte | North Carolina | United States | 28233-3549 |
| 112 | Batte Cancer Center at Northeast Medical Center | Concord | North Carolina | United States | 28025 |
| 113 | Duke Cancer Institute | Durham | North Carolina | United States | 27710 |
| 114 | Wayne Memorial Hospital, Incorporated | Goldsboro | North Carolina | United States | 27534 |
| 115 | Leo W. Jenkins Cancer Center at ECU Medical School | Greenville | North Carolina | United States | 27834 |
| 116 | Pardee Memorial Hospital | Hendersonville | North Carolina | United States | 28791 |
| 117 | Kinston Medical Specialists | Kinston | North Carolina | United States | 28501 |
| 118 | Forsyth Regional Cancer Center at Forsyth Medical Center | Winston-Salem | North Carolina | United States | 27103 |
| 119 | Wake Forest University Comprehensive Cancer Center | Winston-Salem | North Carolina | United States | 27157-1096 |
| 120 | Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center | Columbus | Ohio | United States | 43210-1240 |
| 121 | Oklahoma University Cancer Institute | Oklahoma City | Oklahoma | United States | 73104 |
| 122 | Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital | Pittsburgh | Pennsylvania | United States | 15224-1791 |
| 123 | Rhode Island Hospital Comprehensive Cancer Center | Providence | Rhode Island | United States | 02903 |
| 124 | Miriam Hospital | Providence | Rhode Island | United States | 02906 |
| 125 | McLeod Regional Medical Center | Florence | South Carolina | United States | 29501 |
| 126 | Cancer Centers of the Carolinas - Faris Road | Greenville | South Carolina | United States | 29605 |
| 127 | Cancer Centers of the Carolinas - Grove Commons | Greenville | South Carolina | United States | 29605 |
| 128 | Greenville Hospital Cancer Center | Greenville | South Carolina | United States | 29605 |
| 129 | Cancer Centers of the Carolinas - Eastside | Greenville | South Carolina | United States | 29615 |
| 130 | CCOP - Greenville | Greenville | South Carolina | United States | 29615 |
| 131 | Cancer Centers of the Carolinas - Greer Medical Oncology | Greer | South Carolina | United States | 29650 |
| 132 | Cancer Centers of the Carolinas - Seneca | Seneca | South Carolina | United States | 29672 |
| 133 | Cancer Centers of the Carolinas - Spartanburg | Spartanburg | South Carolina | United States | 29307 |
| 134 | Mountainview Medical | Berlin | Vermont | United States | 05602 |
| 135 | Fletcher Allen Health Care - University Health Center Campus | Burlington | Vermont | United States | 05401 |
| 136 | Danville Regional Medical Center | Danville | Virginia | United States | 24541 |
| 137 | Virginia Commonwealth University Massey Cancer Center | Richmond | Virginia | United States | 23298-0037 |
Sponsors and Collaborators
- Alliance for Clinical Trials in Oncology
- National Cancer Institute (NCI)
Investigators
- Study Chair: Clara Bloomfield, MD, James Cancer Hospital and Solove Research Institute
Study Documents (Full-Text)
None provided.More Information
Publications
- Baldus CD, Tanner SM, Ruppert AS, Whitman SP, Archer KJ, Marcucci G, Caligiuri MA, Carroll AJ, Vardiman JW, Powell BL, Allen SL, Moore JO, Larson RA, Kolitz JE, de la Chapelle A, Bloomfield CD. BAALC expression predicts clinical outcome of de novo acute myeloid leukemia patients with normal cytogenetics: a Cancer and Leukemia Group B Study. Blood. 2003 Sep 1;102(5):1613-8. Epub 2003 May 15.
- Heinonen K, Rao PN, Slack JL, Cruz J, Bloomfield CD, Mrózek K. Isochromosome 12p in two cases of acute myeloid leukaemia without evidence of germ cell tumour. Br J Haematol. 1996 Jun;93(3):677-80.
- Marcucci G, Mrózek K, Ruppert AS, Maharry K, Kolitz JE, Moore JO, Mayer RJ, Pettenati MJ, Powell BL, Edwards CG, Sterling LJ, Vardiman JW, Schiffer CA, Carroll AJ, Larson RA, Bloomfield CD. Prognostic factors and outcome of core binding factor acute myeloid leukemia patients with t(8;21) differ from those of patients with inv(16): a Cancer and Leukemia Group B study. J Clin Oncol. 2005 Aug 20;23(24):5705-17.
- Mrozek K, Carroll AJ, Maharry K, et al.: Central review of cytogenetics is essential for cooperative group clinical and correlative studies of acute leukemia: The Cancer and Leukemia Group B (CALGB) 8461 experience. [Abstract] Blood 104 (11): A-1081, 2004.
- Sekeres MA, Peterson B, Dodge RK, Mayer RJ, Moore JO, Lee EJ, Kolitz J, Baer MR, Schiffer CA, Carroll AJ, Vardiman JW, Davey FR, Bloomfield CD, Larson RA, Stone RM; Cancer and Leukemia Group B. Differences in prognostic factors and outcomes in African Americans and whites with acute myeloid leukemia. Blood. 2004 Jun 1;103(11):4036-42. Epub 2004 Feb 19.
Responsible Party:
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00048958
Other Study ID Numbers:
- CALGB-8461
- NCI-2009-00494
- CDR0000256897
- 3U24CA114725-09S1
First Posted:
Jan 27, 2003
Last Update Posted:
Aug 17, 2021
Last Verified:
Aug 1, 2021