Collecting and Storing Samples of Bone Marrow and Blood From Patients With Relapsed Acute Lymphoblastic Leukemia or Non-Hodgkin Lymphoma
Sponsor
Children's Oncology Group (Other)
Overall Status
Completed
CT.gov ID
NCT00897325
Collaborator
National Cancer Institute (NCI) (NIH)
811
183
159.2
4.4
0
Study Details
Study Description
Brief Summary
This research study is collecting and storing samples of bone marrow and blood from patients with relapsed acute lymphoblastic leukemia or relapsed non-Hodgkin lymphoma. Collecting and storing samples of bone marrow and blood from patients with cancer to study in the laboratory may help doctors learn more about cancer and help predict the recurrence of cancer.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
OBJECTIVES:
-
Establish a mechanism to bank specimens of tumor cells and host germline DNA from patients with acute lymphoblastic leukemia (ALL) at first and subsequent relapse.
-
Make these specimens available to qualified researchers to study the biology of ALL.
OUTLINE: This is a multicenter study.
Patients undergo collection of bone marrow and peripheral blood at diagnosis of relapse and/or at the end of the first month of treatment.
Patients are followed periodically for up to 10 years.
Study Design
Study Type:
Observational
Actual Enrollment
:
811 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
A Children's Oncology Group Protocol for Collecting and Banking Relapsed Acute Lymphoblastic Leukemia Research Specimens
Actual Study Start Date
:
Sep 25, 2006
Actual Primary Completion Date
:
Dec 31, 2019
Actual Study Completion Date
:
Dec 31, 2019
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Ancillary-Correlative (Collecting and banking ALL specimens) Patients undergo collection of bone marrow and peripheral blood at diagnosis of relapse and/or at the end of the first month of treatment. |
Other: Cytology Specimen Collection Procedure
Correlative studies
Other Names:
Other: Laboratory Biomarker Analysis
Correlative studies
|
Outcome Measures
Primary Outcome Measures
- Banking of tumor cells and germline DNA [Not Provided]
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
to 30 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Diagnosis of acute lymphoblastic leukemia (ALL) or prior history of non-Hodgkin lymphoma
-
In first or subsequent marrow relapse with ≥ 25% blasts in bone marrow and/or peripheral blood
-
Bone marrow and/or peripheral blood samples (≥ 5 mL) required at the time of diagnosis of relapse
-
No concurrent systemic antileukemic treatment administered for current relapse
-
Intrathecal chemotherapy allowed
-
On-therapy relapse allowed
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Children's Hospital of Alabama | Birmingham | Alabama | United States | 35233 |
| 2 | University of Alabama at Birmingham Cancer Center | Birmingham | Alabama | United States | 35233 |
| 3 | Phoenix Childrens Hospital | Phoenix | Arizona | United States | 85016 |
| 4 | Banner University Medical Center - Tucson | Tucson | Arizona | United States | 85719 |
| 5 | Arkansas Children's Hospital | Little Rock | Arkansas | United States | 72202-3591 |
| 6 | University of Arkansas for Medical Sciences | Little Rock | Arkansas | United States | 72205 |
| 7 | Kaiser Permanente Downey Medical Center | Downey | California | United States | 90242 |
| 8 | City of Hope Comprehensive Cancer Center | Duarte | California | United States | 91010 |
| 9 | Loma Linda University Medical Center | Loma Linda | California | United States | 92354 |
| 10 | Miller Children's and Women's Hospital Long Beach | Long Beach | California | United States | 90806 |
| 11 | Children's Hospital Los Angeles | Los Angeles | California | United States | 90027 |
| 12 | UCLA / Jonsson Comprehensive Cancer Center | Los Angeles | California | United States | 90095 |
| 13 | Valley Children's Hospital | Madera | California | United States | 93636 |
| 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 | Children's Hospital of Orange County | Orange | California | United States | 92868 |
| 17 | Lucile Packard Children's Hospital Stanford University | Palo Alto | California | United States | 94304 |
| 18 | Sutter Medical Center Sacramento | Sacramento | California | United States | 95816 |
| 19 | University of California Davis Comprehensive Cancer Center | Sacramento | California | United States | 95817 |
| 20 | Rady Children's Hospital - San Diego | San Diego | California | United States | 92123 |
| 21 | Naval Medical Center -San Diego | San Diego | California | United States | 92134 |
| 22 | UCSF Medical Center-Parnassus | San Francisco | California | United States | 94143 |
| 23 | UCSF Medical Center-Mission Bay | San Francisco | California | United States | 94158 |
| 24 | Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | Torrance | California | United States | 90502 |
| 25 | Children's Hospital Colorado | Aurora | Colorado | United States | 80045 |
| 26 | Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center | Denver | Colorado | United States | 80218 |
| 27 | Connecticut Children's Medical Center | Hartford | Connecticut | United States | 06106 |
| 28 | Alfred I duPont Hospital for Children | Wilmington | Delaware | United States | 19803 |
| 29 | MedStar Georgetown University Hospital | Washington | District of Columbia | United States | 20007 |
| 30 | Children's National Medical Center | Washington | District of Columbia | United States | 20010 |
| 31 | Broward Health Medical Center | Fort Lauderdale | Florida | United States | 33316 |
| 32 | Lee Memorial Health System | Fort Myers | Florida | United States | 33901 |
| 33 | Golisano Children's Hospital of Southwest Florida | Fort Myers | Florida | United States | 33908 |
| 34 | University of Florida Health Science Center - Gainesville | Gainesville | Florida | United States | 32610 |
| 35 | Memorial Regional Hospital/Joe DiMaggio Children's Hospital | Hollywood | Florida | United States | 33021 |
| 36 | Nemours Children's Clinic-Jacksonville | Jacksonville | Florida | United States | 32207 |
| 37 | University of Miami Miller School of Medicine-Sylvester Cancer Center | Miami | Florida | United States | 33136 |
| 38 | Miami Cancer Institute | Miami | Florida | United States | 33176 |
| 39 | AdventHealth Orlando | Orlando | Florida | United States | 32803 |
| 40 | Arnold Palmer Hospital for Children | Orlando | Florida | United States | 32806 |
| 41 | Nemours Children's Clinic - Orlando | Orlando | Florida | United States | 32806 |
| 42 | UF Cancer Center at Orlando Health | Orlando | Florida | United States | 32806 |
| 43 | Nemours Children's Hospital | Orlando | Florida | United States | 32827 |
| 44 | Nemours Children's Clinic - Pensacola | Pensacola | Florida | United States | 32504 |
| 45 | Johns Hopkins All Children's Hospital | Saint Petersburg | Florida | United States | 33701 |
| 46 | Tampa General Hospital | Tampa | Florida | United States | 33606 |
| 47 | Saint Joseph's Hospital/Children's Hospital-Tampa | Tampa | Florida | United States | 33607 |
| 48 | Saint Mary's Hospital | West Palm Beach | Florida | United States | 33407 |
| 49 | Children's Healthcare of Atlanta - Egleston | Atlanta | Georgia | United States | 30322 |
| 50 | University of Hawaii Cancer Center | Honolulu | Hawaii | United States | 96813 |
| 51 | Kapiolani Medical Center for Women and Children | Honolulu | Hawaii | United States | 96826 |
| 52 | Saint Luke's Mountain States Tumor Institute | Boise | Idaho | United States | 83712 |
| 53 | Lurie Children's Hospital-Chicago | Chicago | Illinois | United States | 60611 |
| 54 | University of Illinois | Chicago | Illinois | United States | 60612 |
| 55 | University of Chicago Comprehensive Cancer Center | Chicago | Illinois | United States | 60637 |
| 56 | Advocate Children's Hospital-Oak Lawn | Oak Lawn | Illinois | United States | 60453 |
| 57 | Advocate Children's Hospital-Park Ridge | Park Ridge | Illinois | United States | 60068 |
| 58 | Advocate Lutheran General Hospital | Park Ridge | Illinois | United States | 60068 |
| 59 | Saint Jude Midwest Affiliate | Peoria | Illinois | United States | 61637 |
| 60 | Southern Illinois University School of Medicine | Springfield | Illinois | United States | 62702 |
| 61 | Riley Hospital for Children | Indianapolis | Indiana | United States | 46202 |
| 62 | Saint Vincent Hospital and Health Care Center | Indianapolis | Indiana | United States | 46260 |
| 63 | Blank Children's Hospital | Des Moines | Iowa | United States | 50309 |
| 64 | University of Iowa/Holden Comprehensive Cancer Center | Iowa City | Iowa | United States | 52242 |
| 65 | University of Kansas Cancer Center | Kansas City | Kansas | United States | 66160 |
| 66 | University of Kentucky/Markey Cancer Center | Lexington | Kentucky | United States | 40536 |
| 67 | Norton Children's Hospital | Louisville | Kentucky | United States | 40202 |
| 68 | Tulane University Health Sciences Center | New Orleans | Louisiana | United States | 70112 |
| 69 | Children's Hospital New Orleans | New Orleans | Louisiana | United States | 70118 |
| 70 | Ochsner Medical Center Jefferson | New Orleans | Louisiana | United States | 70121 |
| 71 | University of Maryland/Greenebaum Cancer Center | Baltimore | Maryland | United States | 21201 |
| 72 | Sinai Hospital of Baltimore | Baltimore | Maryland | United States | 21215 |
| 73 | Johns Hopkins University/Sidney Kimmel Cancer Center | Baltimore | Maryland | United States | 21287 |
| 74 | Walter Reed National Military Medical Center | Bethesda | Maryland | United States | 20889-5600 |
| 75 | UMass Memorial Medical Center - University Campus | Worcester | Massachusetts | United States | 01655 |
| 76 | Wayne State University/Karmanos Cancer Institute | Detroit | Michigan | United States | 48201 |
| 77 | Ascension Saint John Hospital | Detroit | Michigan | United States | 48236 |
| 78 | Michigan State University Clinical Center | East Lansing | Michigan | United States | 48824-7016 |
| 79 | Hurley Medical Center | Flint | Michigan | United States | 48503 |
| 80 | Helen DeVos Children's Hospital at Spectrum Health | Grand Rapids | Michigan | United States | 49503 |
| 81 | Bronson Methodist Hospital | Kalamazoo | Michigan | United States | 49007 |
| 82 | Kalamazoo Center for Medical Studies | Kalamazoo | Michigan | United States | 49008 |
| 83 | Children's Hospitals and Clinics of Minnesota - Minneapolis | Minneapolis | Minnesota | United States | 55404 |
| 84 | University of Minnesota/Masonic Cancer Center | Minneapolis | Minnesota | United States | 55455 |
| 85 | Mayo Clinic | Rochester | Minnesota | United States | 55905 |
| 86 | University of Mississippi Medical Center | Jackson | Mississippi | United States | 39216 |
| 87 | Columbia Regional | Columbia | Missouri | United States | 65201 |
| 88 | Children's Mercy Hospitals and Clinics | Kansas City | Missouri | United States | 64108 |
| 89 | Washington University School of Medicine | Saint Louis | Missouri | United States | 63110 |
| 90 | Mercy Hospital Saint Louis | Saint Louis | Missouri | United States | 63141 |
| 91 | Children's Hospital and Medical Center of Omaha | Omaha | Nebraska | United States | 68114 |
| 92 | University of Nebraska Medical Center | Omaha | Nebraska | United States | 68198 |
| 93 | University Medical Center of Southern Nevada | Las Vegas | Nevada | United States | 89102 |
| 94 | Nevada Cancer Research Foundation CCOP | Las Vegas | Nevada | United States | 89106 |
| 95 | Sunrise Hospital and Medical Center | Las Vegas | Nevada | United States | 89109 |
| 96 | Alliance for Childhood Diseases/Cure 4 the Kids Foundation | Las Vegas | Nevada | United States | 89135 |
| 97 | Summerlin Hospital Medical Center | Las Vegas | Nevada | United States | 89144 |
| 98 | Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | United States | 03756 |
| 99 | Hackensack University Medical Center | Hackensack | New Jersey | United States | 07601 |
| 100 | Morristown Medical Center | Morristown | New Jersey | United States | 07960 |
| 101 | Saint Peter's University Hospital | New Brunswick | New Jersey | United States | 08901 |
| 102 | Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital | New Brunswick | New Jersey | United States | 08903 |
| 103 | Newark Beth Israel Medical Center | Newark | New Jersey | United States | 07112 |
| 104 | Saint Joseph's Regional Medical Center | Paterson | New Jersey | United States | 07503 |
| 105 | Overlook Hospital | Summit | New Jersey | United States | 07902 |
| 106 | University of New Mexico Cancer Center | Albuquerque | New Mexico | United States | 87102 |
| 107 | Albany Medical Center | Albany | New York | United States | 12208 |
| 108 | Montefiore Medical Center - Moses Campus | Bronx | New York | United States | 10467 |
| 109 | Roswell Park Cancer Institute | Buffalo | New York | United States | 14263 |
| 110 | Laura and Isaac Perlmutter Cancer Center at NYU Langone | New York | New York | United States | 10016 |
| 111 | NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center | New York | New York | United States | 10032 |
| 112 | University of Rochester | Rochester | New York | United States | 14642 |
| 113 | Stony Brook University Medical Center | Stony Brook | New York | United States | 11794 |
| 114 | State University of New York Upstate Medical University | Syracuse | New York | United States | 13210 |
| 115 | New York Medical College | Valhalla | New York | United States | 10595 |
| 116 | Mission Hospital | Asheville | North Carolina | United States | 28801 |
| 117 | UNC Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina | United States | 27599 |
| 118 | Carolinas Medical Center/Levine Cancer Institute | Charlotte | North Carolina | United States | 28203 |
| 119 | Novant Health Presbyterian Medical Center | Charlotte | North Carolina | United States | 28204 |
| 120 | Duke University Medical Center | Durham | North Carolina | United States | 27710 |
| 121 | East Carolina University | Greenville | North Carolina | United States | 27834 |
| 122 | Wake Forest University Health Sciences | Winston-Salem | North Carolina | United States | 27157 |
| 123 | Sanford Broadway Medical Center | Fargo | North Dakota | United States | 58122 |
| 124 | Children's Hospital Medical Center of Akron | Akron | Ohio | United States | 44308 |
| 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 | Dayton Children's Hospital | Dayton | Ohio | United States | 45404 |
| 129 | University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | United States | 73104 |
| 130 | Legacy Emanuel Children's Hospital | Portland | Oregon | United States | 97227 |
| 131 | Legacy Emanuel Hospital and Health Center | Portland | Oregon | United States | 97227 |
| 132 | Oregon Health and Science University | Portland | Oregon | United States | 97239 |
| 133 | Lehigh Valley Hospital - Muhlenberg | Bethlehem | Pennsylvania | United States | 18017 |
| 134 | Penn State Children's Hospital | Hershey | Pennsylvania | United States | 17033 |
| 135 | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | United States | 19104 |
| 136 | Childrens Oncology Group | Philadelphia | Pennsylvania | United States | 19104 |
| 137 | Saint Christopher's Hospital for Children | Philadelphia | Pennsylvania | United States | 19134 |
| 138 | Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania | United States | 15224 |
| 139 | Rhode Island Hospital | Providence | Rhode Island | United States | 02903 |
| 140 | Prisma Health Richland Hospital | Columbia | South Carolina | United States | 29203 |
| 141 | BI-LO Charities Children's Cancer Center | Greenville | South Carolina | United States | 29605 |
| 142 | Greenville Cancer Treatment Center | Greenville | South Carolina | United States | 29605 |
| 143 | Sanford USD Medical Center - Sioux Falls | Sioux Falls | South Dakota | United States | 57117-5134 |
| 144 | T C Thompson Children's Hospital | Chattanooga | Tennessee | United States | 37403 |
| 145 | East Tennessee Childrens Hospital | Knoxville | Tennessee | United States | 37916 |
| 146 | Vanderbilt University/Ingram Cancer Center | Nashville | Tennessee | United States | 37232 |
| 147 | Texas Tech University Health Sciences Center-Amarillo | Amarillo | Texas | United States | 79106 |
| 148 | Driscoll Children's Hospital | Corpus Christi | Texas | United States | 78411 |
| 149 | Medical City Dallas Hospital | Dallas | Texas | United States | 75230 |
| 150 | UT Southwestern/Simmons Cancer Center-Dallas | Dallas | Texas | United States | 75390 |
| 151 | Brooke Army Medical Center | Fort Sam Houston | Texas | United States | 78234 |
| 152 | Cook Children's Medical Center | Fort Worth | Texas | United States | 76104 |
| 153 | Covenant Children's Hospital | Lubbock | Texas | United States | 79410 |
| 154 | Children's Hospital of San Antonio | San Antonio | Texas | United States | 78207 |
| 155 | Methodist Children's Hospital of South Texas | San Antonio | Texas | United States | 78229 |
| 156 | University of Texas Health Science Center at San Antonio | San Antonio | Texas | United States | 78229 |
| 157 | Primary Children's Hospital | Salt Lake City | Utah | United States | 84113 |
| 158 | University of Vermont and State Agricultural College | Burlington | Vermont | United States | 05405 |
| 159 | Children's Hospital of The King's Daughters | Norfolk | Virginia | United States | 23507 |
| 160 | Carilion Clinic Children's Hospital | Roanoke | Virginia | United States | 24014 |
| 161 | Seattle Children's Hospital | Seattle | Washington | United States | 98105 |
| 162 | Providence Sacred Heart Medical Center and Children's Hospital | Spokane | Washington | United States | 99204 |
| 163 | Mary Bridge Children's Hospital and Health Center | Tacoma | Washington | United States | 98405 |
| 164 | Madigan Army Medical Center | Tacoma | Washington | United States | 98431 |
| 165 | West Virginia University Charleston Division | Charleston | West Virginia | United States | 25304 |
| 166 | Saint Vincent Hospital Cancer Center Green Bay | Green Bay | Wisconsin | United States | 54301 |
| 167 | Marshfield Medical Center-Marshfield | Marshfield | Wisconsin | United States | 54449 |
| 168 | Children's Hospital of Wisconsin | Milwaukee | Wisconsin | United States | 53226 |
| 169 | Princess Margaret Hospital for Children | Perth | Western Australia | Australia | 6008 |
| 170 | British Columbia Children's Hospital | Vancouver | British Columbia | Canada | V6H 3V4 |
| 171 | CancerCare Manitoba | Winnipeg | Manitoba | Canada | R3E 0V9 |
| 172 | IWK Health Centre | Halifax | Nova Scotia | Canada | B3K 6R8 |
| 173 | Kingston Health Sciences Centre | Kingston | Ontario | Canada | K7L 2V7 |
| 174 | Children's Hospital | London | Ontario | Canada | N6A 5W9 |
| 175 | Children's Hospital of Eastern Ontario | Ottawa | Ontario | Canada | K1H 8L1 |
| 176 | Hospital for Sick Children | Toronto | Ontario | Canada | M5G 1X8 |
| 177 | The Montreal Children's Hospital of the MUHC | Montreal | Quebec | Canada | H3H 1P3 |
| 178 | Centre Hospitalier Universitaire Sainte-Justine | Montreal | Quebec | Canada | H3T 1C5 |
| 179 | Allan Blair Cancer Centre | Regina | Saskatchewan | Canada | S4T 7T1 |
| 180 | Saskatoon Cancer Centre | Saskatoon | Saskatchewan | Canada | S7N 4H4 |
| 181 | San Jorge Children's Hospital | San Juan | Puerto Rico | 00912 | |
| 182 | University Pediatric Hospital | San Juan | Puerto Rico | 00926 | |
| 183 | Swiss Pediatric Oncology Group - Bern | Bern | Switzerland | 3010 |
Sponsors and Collaborators
- Children's Oncology Group
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Stephen P Hunger, Children's Oncology Group
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00897325
Other Study ID Numbers:
- AALL05B1
- NCI-2009-00310
- COG-AALL05B1
- CDR0000491159
- AALL05B1
- AALL05B1
- U10CA098543
- UG1CA189958
First Posted:
May 12, 2009
Last Update Posted:
Jan 18, 2020
Last Verified:
Jan 1, 2020
Additional relevant MeSH terms: