Risk-Group Classification of Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
Sponsor
Children's Oncology Group (Other)
Overall Status
Completed
CT.gov ID
NCT00482352
Collaborator
National Cancer Institute (NCI) (NIH)
11,196
200
56
Study Details
Study Description
Brief Summary
This clinical trial is studying risk-group classification of patients with newly diagnosed acute lymphoblastic leukemia. Developing a risk-group classification guide may help doctors assign patients with newly diagnosed acute lymphoblastic leukemia to treatment clinical trials.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
OBJECTIVES:
-
Provide a classification guide that will organize the clinical and laboratory data necessary for assigning each patient with newly diagnosed acute lymphoblastic leukemia (ALL) to a specific treatment clinical trial.
-
Provide an administrative base to capture classification data for correlative studies accompanying current Children's Oncology Group (COG) ALL treatment clinical trials.
-
Provide a central reference guide for all required and research only ALL studies that will be conducted at local and reference laboratories.
-
Provide a mechanism for optional banking of leukemia and germline specimens for current and future research.
OUTLINE:
Patients undergo blood collection and bone marrow biopsies at baseline and at the end of induction therapy for immunophenotyping for marker identification; molecular testing for translocations; trisomy analysis by fluorescence in situ hybridization (FISH); and DNA ploidy. Immunophenotype results obtained on this study are used to determine the patient's assignment to specific treatment clinical trials (consistent with acute lymphoblastic leukemia).
After completion of induction therapy, patients are followed once or twice annually.
Study Design
Study Type:
Observational
Actual Enrollment
:
11196 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Classification Of Acute Lymphoblastic Leukemia
Study Start Date
:
Dec 1, 2003
Actual Primary Completion Date
:
Apr 1, 2012
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Ancillary-Correlative (marker identification, molecular test) Patients undergo blood collection and bone marrow biopsies at baseline and at the end of induction therapy for immunophenotyping for marker identification; molecular testing for translocations; trisomy analysis by fluorescence in situ hybridization (FISH); and DNA ploidy. Immunophenotype results obtained on this study are used to determine the patient's assignment to specific treatment clinical trials (consistent with acute lymphoblastic leukemia). |
Other: laboratory biomarker analysis
Correlative studies
|
Outcome Measures
Primary Outcome Measures
- Development of a classification guide to help determine patient assignment to a specific treatment clinical trial for newly diagnosed acute lymphoblastic leukemia (ALL) [Up to 5 years]
- Development of a classification database for correlative studies [Up to 5 years]
- Development of a central reference guide for all required and research only ALL studies [Up to 5 years]
- Development of a leukemia and germline specimen bank for current and future research [Up to 5 years]
Eligibility Criteria
Criteria
Ages Eligible for Study:
1 Year
to 30 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Newly diagnosed acute lymphoblastic leukemia, defined by any of the following:
-
At least 25% blasts in the bone marrow
-
Absolute blast count at least 10,000/mm^3, if bone marrow aspiration is not performed
-
No prior registration on this study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Alabama at Birmingham | Birmingham | Alabama | United States | 35294 |
| 2 | University of South Alabama | Mobile | Alabama | United States | 36604 |
| 3 | Phoenix Childrens Hospital | Phoenix | Arizona | United States | 85016 |
| 4 | University of Arizona Health Sciences Center | Tucson | Arizona | United States | 85724 |
| 5 | University of Arkansas for Medical Sciences | Little Rock | Arkansas | United States | 72205 |
| 6 | Southern California Permanente Medical Group | Downey | California | United States | 90242 |
| 7 | City of Hope Medical Center | Duarte | California | United States | 91010 |
| 8 | Loma Linda University Medical Center | Loma Linda | California | United States | 92354 |
| 9 | Miller Children's Hospital | Long Beach | California | United States | 90806 |
| 10 | Children's Hospital Los Angeles | Los Angeles | California | United States | 90027 |
| 11 | Cedars-Sinai Medical Center | Los Angeles | California | United States | 90048 |
| 12 | David Geffen School of Medicine at UCLA | Los Angeles | California | United States | 90095 |
| 13 | Children's Hospital Central California | Madera | California | United States | 93636-8762 |
| 14 | Children's Hospital and Research Center at Oakland | Oakland | California | United States | 94609-1809 |
| 15 | Kaiser Permanente-Oakland | Oakland | California | United States | 94611 |
| 16 | Childrens Hospital of Orange County | Orange | California | United States | 92868-3874 |
| 17 | Lucile Packard Children's Hospital Stanford University | Palo Alto | California | United States | 94304 |
| 18 | UC Davis Comprehensive Cancer Center | Sacramento | California | United States | 95817 |
| 19 | Rady Children's Hospital - San Diego | San Diego | California | United States | 92123 |
| 20 | University of California San Francisco Medical Center-Parnassus | San Francisco | California | United States | 94143 |
| 21 | Children's Hospital Colorado | Aurora | Colorado | United States | 80045 |
| 22 | Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center | Denver | Colorado | United States | 80218 |
| 23 | Connecticut Children's Medical Center | Hartford | Connecticut | United States | 06106 |
| 24 | Yale University | New Haven | Connecticut | United States | 06520 |
| 25 | Alfred I duPont Hospital for Children | Wilmington | Delaware | United States | 19803 |
| 26 | Children's National Medical Center | Washington | District of Columbia | United States | 20010 |
| 27 | Lombardi Comprehensive Cancer Center at Georgetown University | Washington | District of Columbia | United States | 20057 |
| 28 | Broward Health Medical Center | Fort Lauderdale | Florida | United States | 33316 |
| 29 | Lee Memorial Health System | Fort Myers | Florida | United States | 33901 |
| 30 | University of Florida | Gainesville | Florida | United States | 32610 |
| 31 | Memorial Healthcare System - Joe DiMaggio Children's Hospital | Hollywood | Florida | United States | 33021 |
| 32 | Nemours Children's Clinic - Jacksonville | Jacksonville | Florida | United States | 32207-8426 |
| 33 | University of Miami Miller School of Medicine-Sylvester Cancer Center | Miami | Florida | United States | 33136 |
| 34 | Miami Children's Hospital | Miami | Florida | United States | 33155 |
| 35 | Baptist Hospital of Miami | Miami | Florida | United States | 33176 |
| 36 | Florida Hospital | Orlando | Florida | United States | 32803 |
| 37 | Nemours Childrens Clinic - Orlando | Orlando | Florida | United States | 32806 |
| 38 | UF Cancer Center at Orlando Health | Orlando | Florida | United States | 32806 |
| 39 | Nemours Children's Clinic - Pensacola | Pensacola | Florida | United States | 32504 |
| 40 | All Children's Hospital | Saint Petersburg | Florida | United States | 33701 |
| 41 | Saint Joseph Children's Hospital of Tampa | Tampa | Florida | United States | 33607 |
| 42 | Saint Mary's Hospital | West Palm Beach | Florida | United States | 33407 |
| 43 | Children's Healthcare of Atlanta - Egleston | Atlanta | Georgia | United States | 30322 |
| 44 | Georgia Regents University | Augusta | Georgia | United States | 30912 |
| 45 | Memorial Health University Medical Center | Savannah | Georgia | United States | 31403 |
| 46 | University of Hawaii | Honolulu | Hawaii | United States | 96813 |
| 47 | Tripler Army Medical Center | Honolulu | Hawaii | United States | 96859 |
| 48 | Saint Luke's Mountain States Tumor Institute | Boise | Idaho | United States | 83712 |
| 49 | University of Illinois | Chicago | Illinois | United States | 60612 |
| 50 | Lurie Children's Hospital-Chicago | Chicago | Illinois | United States | 60614 |
| 51 | University of Chicago | Chicago | Illinois | United States | 60637 |
| 52 | Loyola University Medical Center | Maywood | Illinois | United States | 60153 |
| 53 | Advocate Children's Hospital-Oak Lawn | Oak Lawn | Illinois | United States | 60453 |
| 54 | Advocate Lutheran General Hospital. | Park Ridge | Illinois | United States | 60068 |
| 55 | Saint Jude Midwest Affiliate | Peoria | Illinois | United States | 61602 |
| 56 | Southern Illinois University | Springfield | Illinois | United States | 62702 |
| 57 | Indiana University Medical Center | Indianapolis | Indiana | United States | 46202 |
| 58 | Saint Vincent Hospital and Health Services | Indianapolis | Indiana | United States | 46260 |
| 59 | Blank Children's Hospital | Des Moines | Iowa | United States | 50309 |
| 60 | University of Iowa Hospitals and Clinics | Iowa City | Iowa | United States | 52242 |
| 61 | University of Kentucky | Lexington | Kentucky | United States | 40536 |
| 62 | Kosair Children's Hospital | Louisville | Kentucky | United States | 40202 |
| 63 | Tulane University Health Sciences Center | New Orleans | Louisiana | United States | 70112 |
| 64 | Children's Hospital-Main Campus | New Orleans | Louisiana | United States | 70118 |
| 65 | Eastern Maine Medical Center | Bangor | Maine | United States | 04401 |
| 66 | Maine Children's Cancer Program | Scarborough | Maine | United States | 04074 |
| 67 | University of Maryland Greenebaum Cancer Center | Baltimore | Maryland | United States | 21201-1595 |
| 68 | Sinai Hospital of Baltimore | Baltimore | Maryland | United States | 21215 |
| 69 | Johns Hopkins University | Baltimore | Maryland | United States | 21287 |
| 70 | Walter Reed National Military Medical Center | Bethesda | Maryland | United States | 20889-5600 |
| 71 | Massachusetts General Hospital Cancer Center | Boston | Massachusetts | United States | 02114 |
| 72 | Baystate Medical Center | Springfield | Massachusetts | United States | 01199 |
| 73 | University of Massachusetts Medical School | Worcester | Massachusetts | United States | 01655 |
| 74 | C S Mott Children's Hospital | Ann Arbor | Michigan | United States | 48109 |
| 75 | Wayne State University-Karmanos Cancer Institute | Detroit | Michigan | United States | 48201 |
| 76 | Saint John Hospital and Medical Center | Detroit | Michigan | United States | 48236 |
| 77 | Hurley Medical Center | Flint | Michigan | United States | 48502 |
| 78 | Helen DeVos Children's Hospital at Spectrum Health | Grand Rapids | Michigan | United States | 49503 |
| 79 | Kalamazoo Center for Medical Studies | Kalamazoo | Michigan | United States | 49008 |
| 80 | Michigan State University - Breslin Cancer Center | Lansing | Michigan | United States | 48910 |
| 81 | William Beaumont Hospital-Royal Oak | Royal Oak | Michigan | United States | 48073 |
| 82 | Children's Hospitals and Clinics of Minnesota - Minneapolis | Minneapolis | Minnesota | United States | 55404 |
| 83 | University of Minnesota Medical Center-Fairview | Minneapolis | Minnesota | United States | 55455 |
| 84 | Mayo Clinic | Rochester | Minnesota | United States | 55905 |
| 85 | University of Mississippi Medical Center | Jackson | Mississippi | United States | 39216 |
| 86 | University of Missouri-Columbia | Columbia | Missouri | United States | 65212 |
| 87 | The Childrens Mercy Hospital | Kansas City | Missouri | United States | 64108 |
| 88 | Cardinal Glennon Children's Medical Center | Saint Louis | Missouri | United States | 63104 |
| 89 | Washington University School of Medicine | Saint Louis | Missouri | United States | 63110 |
| 90 | Children's Hospital and Medical Center of Omaha | Omaha | Nebraska | United States | 68114 |
| 91 | University of Nebraska Medical Center | Omaha | Nebraska | United States | 68198 |
| 92 | Nevada Cancer Research Foundation CCOP | Las Vegas | Nevada | United States | 89106 |
| 93 | Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | United States | 03756 |
| 94 | Hackensack University Medical Center | Hackensack | New Jersey | United States | 07601 |
| 95 | Saint Peter's University Hospital | New Brunswick | New Jersey | United States | 08901 |
| 96 | UMDNJ - Robert Wood Johnson University Hospital | New Brunswick | New Jersey | United States | 08903 |
| 97 | Newark Beth Israel Medical Center | Newark | New Jersey | United States | 07112 |
| 98 | Saint Joseph's Regional Medical Center | Paterson | New Jersey | United States | 07503 |
| 99 | Overlook Hospital | Summit | New Jersey | United States | 07902 |
| 100 | University of New Mexico Cancer Center | Albuquerque | New Mexico | United States | 87106 |
| 101 | Albany Medical Center | Albany | New York | United States | 12208 |
| 102 | Montefiore Medical Center | Bronx | New York | United States | 10467-2490 |
| 103 | Brooklyn Hospital Center | Brooklyn | New York | United States | 11201 |
| 104 | Roswell Park Cancer Institute | Buffalo | New York | United States | 14263 |
| 105 | Winthrop University Hospital | Mineola | New York | United States | 11501 |
| 106 | The Steven and Alexandra Cohen Children's Medical Center of New York | New Hyde Park | New York | United States | 11040 |
| 107 | New York University Langone Medical Center | New York | New York | United States | 10016 |
| 108 | Mount Sinai Medical Center | New York | New York | United States | 10029 |
| 109 | Memorial Sloan-Kettering Cancer Center | New York | New York | United States | 10065 |
| 110 | Weill Medical College of Cornell University | New York | New York | United States | 10065 |
| 111 | University of Rochester | Rochester | New York | United States | 14642 |
| 112 | Stony Brook University Medical Center | Stony Brook | New York | United States | 11794 |
| 113 | State University of New York Upstate Medical University | Syracuse | New York | United States | 13210 |
| 114 | Ny Cancer% | Valhalla | New York | United States | 10595 |
| 115 | Mission Hospitals | Asheville | North Carolina | United States | 28801 |
| 116 | University of North Carolina | Chapel Hill | North Carolina | United States | 27599 |
| 117 | Carolinas Medical Center | Charlotte | North Carolina | United States | 28203 |
| 118 | Presbyterian Hospital | Charlotte | North Carolina | United States | 28204 |
| 119 | Duke University Medical Center | Durham | North Carolina | United States | 27710 |
| 120 | East Carolina University | Greenville | North Carolina | United States | 27858 |
| 121 | Wake Forest University Health Sciences | Winston-Salem | North Carolina | United States | 27157 |
| 122 | Sanford Medical Center-Fargo | Fargo | North Dakota | United States | 58122 |
| 123 | Children's Hospital Medical Center of Akron | Akron | Ohio | United States | 44308 |
| 124 | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | United States | 45229 |
| 125 | Rainbow Babies and Childrens Hospital | Cleveland | Ohio | United States | 44106 |
| 126 | Cleveland Clinic Foundation | Cleveland | Ohio | United States | 44195 |
| 127 | Nationwide Children's Hospital | Columbus | Ohio | United States | 43205 |
| 128 | The Children's Medical Center of Dayton | Dayton | Ohio | United States | 45404 |
| 129 | The Toledo Hospital/Toledo Children's Hospital | Toledo | Ohio | United States | 43606 |
| 130 | Mercy Children's Hospital | Toledo | Ohio | United States | 43608 |
| 131 | University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | United States | 73104 |
| 132 | Natalie W Bryant Cancer Center | Tulsa | Oklahoma | United States | 74136 |
| 133 | Legacy Emanuel Hospital and Health Center | Portland | Oregon | United States | 97227 |
| 134 | Oregon Health and Science University | Portland | Oregon | United States | 97239 |
| 135 | Lehigh Valley Hospital - Muhlenberg | Bethlehem | Pennsylvania | United States | 18017 |
| 136 | Geisinger Medical Center | Danville | Pennsylvania | United States | 17822-2001 |
| 137 | Penn State Hershey Children's Hospital | Hershey | Pennsylvania | United States | 17033 |
| 138 | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | United States | 19104 |
| 139 | Saint Christopher's Hospital for Children | Philadelphia | Pennsylvania | United States | 19134 |
| 140 | Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania | United States | 15224 |
| 141 | Rhode Island Hospital | Providence | Rhode Island | United States | 02903 |
| 142 | Medical University of South Carolina | Charleston | South Carolina | United States | 29425 |
| 143 | Palmetto Health Richland | Columbia | South Carolina | United States | 29203 |
| 144 | Greenville Cancer Treatment Center | Greenville | South Carolina | United States | 29605 |
| 145 | T C Thompson Children's Hospital | Chattanooga | Tennessee | United States | 37403 |
| 146 | East Tennessee Childrens Hospital | Knoxville | Tennessee | United States | 37916 |
| 147 | Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | United States | 37232 |
| 148 | Texas Tech University Health Science Center-Amarillo | Amarillo | Texas | United States | 79106 |
| 149 | Dell Children's Medical Center of Central Texas | Austin | Texas | United States | 78723 |
| 150 | Driscoll Children's Hospital | Corpus Christi | Texas | United States | 78411 |
| 151 | Medical City Dallas Hospital | Dallas | Texas | United States | 75230 |
| 152 | University of Texas Southwestern Medical Center | Dallas | Texas | United States | 75390 |
| 153 | Cook Children's Medical Center | Fort Worth | Texas | United States | 76104 |
| 154 | Baylor College of Medicine | Houston | Texas | United States | 77030 |
| 155 | M D Anderson Cancer Center | Houston | Texas | United States | 77030 |
| 156 | Covenant Children's Hospital | Lubbock | Texas | United States | 79410 |
| 157 | University of Texas Health Science Center at San Antonio | San Antonio | Texas | United States | 78229-3900 |
| 158 | Methodist Children's Hospital of South Texas | San Antonio | Texas | United States | 78229 |
| 159 | Scott and White Memorial Hospital | Temple | Texas | United States | 76508 |
| 160 | Primary Children's Hospital | Salt Lake City | Utah | United States | 84113 |
| 161 | University of Vermont | Burlington | Vermont | United States | 05401 |
| 162 | University of Virginia | Charlottesville | Virginia | United States | 22908 |
| 163 | Inova Fairfax Hospital | Falls Church | Virginia | United States | 22042 |
| 164 | Childrens Hospital-King's Daughters | Norfolk | Virginia | United States | 23507 |
| 165 | Naval Medical Center - Portsmouth | Portsmouth | Virginia | United States | 23708-2197 |
| 166 | Virginia Commonwealth University | Richmond | Virginia | United States | 23298 |
| 167 | Carilion Clinic Children's Hospital | Roanoke | Virginia | United States | 24014 |
| 168 | Seattle Children's Hospital | Seattle | Washington | United States | 98105 |
| 169 | Providence Sacred Heart Medical Center and Children's Hospital | Spokane | Washington | United States | 99204 |
| 170 | Mary Bridge Children's Hospital and Health Center | Tacoma | Washington | United States | 98405 |
| 171 | Madigan Army Medical Center | Tacoma | Washington | United States | 98431 |
| 172 | West Virginia University Charleston | Charleston | West Virginia | United States | 25304 |
| 173 | Saint Vincent Hospital | Green Bay | Wisconsin | United States | 54301 |
| 174 | University of Wisconsin Hospital and Clinics | Madison | Wisconsin | United States | 53792 |
| 175 | Marshfield Clinic | Marshfield | Wisconsin | United States | 54449 |
| 176 | Midwest Children's Cancer Center | Milwaukee | Wisconsin | United States | 53226 |
| 177 | The Children's Hospital at Westmead | Westmead | New South Wales | Australia | 2145 |
| 178 | Royal Brisbane and Women's Hospital | Herston | Queensland | Australia | 4029 |
| 179 | Women's and Children's Hospital-Adelaide | North Adelaide | South Australia | Australia | 5006 |
| 180 | Royal Children's Hospital | Parkville | Victoria | Australia | 3052 |
| 181 | Princess Margaret Hospital for Children | Perth | Western Australia | Australia | 6008 |
| 182 | Alberta Children's Hospital | Calgary | Alberta | Canada | T3B 6A8 |
| 183 | University of Alberta Hospital | Edmonton | Alberta | Canada | T6G 2B7 |
| 184 | British Columbia Children's Hospital | Vancouver | British Columbia | Canada | V6H 3V4 |
| 185 | CancerCare Manitoba | Winnipeg | Manitoba | Canada | R3E 0V9 |
| 186 | Janeway Child Health Centre | Saint John's | Newfoundland and Labrador | Canada | A1B 3V6 |
| 187 | IWK Health Centre | Halifax | Nova Scotia | Canada | B3J 3G9 |
| 188 | Cancer Centre of Southeastern Ontario at Kingston General Hospital | Kingston | Ontario | Canada | K7L 5P9 |
| 189 | Children's Hospital | London | Ontario | Canada | N6A 5W9 |
| 190 | Children's Hospital of Eastern Ontario | Ottawa | Ontario | Canada | K1H 8L1 |
| 191 | Hospital for Sick Children | Toronto | Ontario | Canada | M5G 1X8 |
| 192 | The Montreal Children's Hospital of the MUHC | Montreal | Quebec | Canada | H3H 1P3 |
| 193 | Allan Blair Cancer Centre | Regina | Saskatchewan | Canada | S4T 7T1 |
| 194 | Saskatoon Cancer Centre | Saskatoon | Saskatchewan | Canada | S7N 4H4 |
| 195 | Starship Children's Hospital | Grafton | Auckland | New Zealand | 1145 |
| 196 | Christchurch Hospital | Christchurch | New Zealand | 8011 | |
| 197 | San Jorge Children's Hospital | Santurce | Puerto Rico | 00912 | |
| 198 | Swiss Pediatric Oncology Group - Bern | Bern | Switzerland | 3010 | |
| 199 | Swiss Pediatric Oncology Group - Geneva | Geneva | Switzerland | 1205 | |
| 200 | Swiss Pediatric Oncology Group - Lausanne | Lausanne | Switzerland | 1011 |
Sponsors and Collaborators
- Children's Oncology Group
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Mignon Loh, MD, Children's Oncology Group
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00482352
Other Study ID Numbers:
- AALL03B1
- NCI-2009-00303
- COG-AALL03B1
- CDR0000344369
- AALL03B1
- AALL03B1
- U10CA098543
- NCT00228722
First Posted:
Jun 5, 2007
Last Update Posted:
Feb 23, 2016
Last Verified:
Feb 1, 2016
Additional relevant MeSH terms: