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Classification of Newly Diagnosed Acute Lymphoblastic Leukemia

30 Years
Open (Enrolling)

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Trial Information

Classification of Newly Diagnosed Acute Lymphoblastic Leukemia


- To provide a risk-based classification system based on clinical, pathological,
molecular, and early response data that will be used to assign all patients with newly
diagnosed acute lymphoblastic leukemia (ALL) to the Children's Oncology Group (COG)
frontline specific-treatment studies.

- To capture classification data for correlative studies accompanying current COG ALL
treatment protocols.

- To provide a central reference guide for all required and research studies that will be
conducted in local and reference laboratories for all newly diagnosed ALL patients.

- To provide a mechanism for optional banking of leukemia and germline specimens for
current and future research.

OUTLINE: This is a multicenter study. Patients are stratified according to diagnosis (B-cell
precursor vs infant vs T-cell acute lymphoblastic leukemia [ALL]).

Patients undergo blood sample collection and bone marrow biopsies at baseline and during and
after induction therapy for immunophenotyping for ALL confirmation and classification, DNA
ploidy, genomic variation, and cytogenetic (BCR-ABL, trisomies 4+10, and molecular testing
for translocations) analysis by flow cytometry and FISH. Immunophenotype results obtained on
this study are used to determine patient's assignment to specific clinical-trial treatments.

Some samples (leukemic and germline) may be banked for current and/or future analyses.

Inclusion Criteria


- Newly diagnosed acute leukemia meeting 1 of the following criteria:

- ≥ 25% blasts by bone marrow aspirate

- Acute leukemia diagnosed by bone marrow biopsy

- Complete blood count with documented leukemia blasts of ≥ 1,000/μL

- Patients with suspected acute lymphoblastic leukemia (ALL) who have true biphenotypic
or bilineage leukemia (i.e., patient with significant blasts expression of multiple
lymphoid and myeloid markers that cannot be assignment to a single lineage) are
allowed to enroll in AALL08B1 cell banking

- No patients with blast-myeloid morphology or whose blasts are myeloperoxidase

- Patients with high-risk or very high-risk disease may enroll in AALL1131

- No secondary ALL


- Not specified


- No prior cytotoxic therapy

- Prior steroids or intrathecal chemotherapy allowed

Type of Study:


Study Design:


Outcome Measure:

Development of a risk-based classification system to be used to assign patients newly diagnosed with acute lymphoblastic leukemia (ALL) to frontline specific-treatment studies

Outcome Time Frame:

Up to 5 years

Safety Issue:


Principal Investigator

Karen Rabin, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Texas Children's Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

August 2010

Completion Date:

Related Keywords:

  • Leukemia
  • untreated adult acute lymphoblastic leukemia
  • untreated childhood acute lymphoblastic leukemia
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma



National Naval Medical Center Bethesda, Maryland  20889
Roswell Park Cancer Institute Buffalo, New York  14263
Memorial Sloan-Kettering Cancer Center New York, New York  10021
Children's Hospital of Philadelphia Philadelphia, Pennsylvania  19104
Mayo Clinic Cancer Center Rochester, Minnesota  55905
Cardinal Bernardin Cancer Center at Loyola University Medical Center Maywood, Illinois  60153-5500
University of Chicago Cancer Research Center Chicago, Illinois  60637
Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201
Tripler Army Medical Center Honolulu, Hawaii  96859-5000
Hurley Medical Center Flint, Michigan  48503
Medical City Dallas Hospital Dallas, Texas  75230
University of Texas Health Science Center at San Antonio San Antonio, Texas  78284-7811
Presbyterian - St. Luke's Medical Center Denver, Colorado  80218
Van Elslander Cancer Center at St. John Hospital and Medical Center Grosse Pointe Woods, Michigan  48236
Bronson Methodist Hospital Kalamazoo, Michigan  49007
CCOP - MeritCare Hospital Fargo, North Dakota  58122
Natalie Warren Bryant Cancer Center at St. Francis Hospital Tulsa, Oklahoma  74136
Sanford Cancer Center at Sanford USD Medical Center Sioux Falls, South Dakota  57117-5039
Vanderbilt-Ingram Cancer Center Nashville, Tennessee  37232-6838
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center Madison, Wisconsin  53792-6164
Marshfield Clinic - Marshfield Center Marshfield, Wisconsin  54449
Newark Beth Israel Medical Center Newark, New Jersey  07112
New York Medical College Valhalla, New York  10595
Holden Comprehensive Cancer Center at University of Iowa Iowa City, Iowa  52242-1002
UMASS Memorial Cancer Center - University Campus Worcester, Massachusetts  01605-2982
Ellis Fischel Cancer Center at University of Missouri - Columbia Columbia, Missouri  65203
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center Lebanon, New Hampshire  03756-0002
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill Chapel Hill, North Carolina  27599-7570
CCOP - Scott and White Hospital Temple, Texas  76508
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore, Maryland  21231-2410
Cancer Research Center of Hawaii Honolulu, Hawaii  96813
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195
Brooke Army Medical Center Fort Sam Houston, Texas  78234-6200
Children's Hospital of Orange County Orange, California  92668
Children's National Medical Center Washington, District of Columbia  20010-2970
Children's Mercy Hospital Kansas City, Missouri  64108
St. Joseph's Hospital and Medical Center Paterson, New Jersey  07503
Children's Hospital and Regional Medical Center - Seattle Seattle, Washington  98105
University of California Davis Cancer Center Sacramento, California  95817
Nemours Children's Clinic Jacksonville, Florida  32207
Miami Children's Hospital Miami, Florida  33155-4069
All Children's Hospital St. Petersburg, Florida  33701
Children's Memorial Hospital - Chicago Chicago, Illinois  60614
Children's Hospital of New Orleans New Orleans, Louisiana  70118
Cardinal Glennon Children's Hospital Saint Louis, Missouri  63104
Schneider Children's Hospital New Hyde Park, New York  11042
St. Christopher's Hospital for Children Philadelphia, Pennsylvania  19134-1095
Driscoll Children's Hospital Corpus Christi, Texas  78466
Cook Children's Medical Center - Fort Worth Fort Worth, Texas  76104
Inova Fairfax Hospital Falls Church, Virginia  22042-3300
City of Hope Comprehensive Cancer Center Duarte, California  91010
Fletcher Allen Health Care - University Health Center Campus Burlington, Vermont  05401
Phoenix Children's Hospital Phoenix, Arizona  85016-7710
Southern California Permanente Medical Group Downey, California  90242
Children's Hospital Central California Madera, California  93638-8762
Kosair Children's Hospital Louisville, Kentucky  40202-3830
Brooklyn Hospital Center Brooklyn, New York  11201
Palmetto Health South Carolina Cancer Center Columbia, South Carolina  29203
East Tennessee Children's Hospital Knoxville, Tennessee  37901
Covenant Children's Hospital Lubbock, Texas  79410
Children's Hospital of the King's Daughters Norfolk, Virginia  23507
Midwest Children's Cancer Center at Children's Hospital of Wisconsin Milwaukee, Wisconsin  53226
Arizona Cancer Center at University of Arizona Health Sciences Center Tucson, Arizona  85724
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences Little Rock, Arkansas  72205
Blumenthal Cancer Center at Carolinas Medical Center Charlotte, North Carolina  28232-2861
Carol G. Simon Cancer Center at Morristown Memorial Hospital Morristown, New Jersey  07962
Winthrop University Hospital Mineola, New York  11501
Loma Linda University Cancer Institute at Loma Linda University Medical Center Loma Linda, California  92354
Jonathan Jaques Children's Cancer Center at Miller Children's Hospital Long Beach, California  90801
Kaiser Permanente Medical Center - Oakland Sacramento, California  95825
Santa Barbara Cottage Children's Hospital Santa Barbara, California  93105
Yale Cancer Center New Haven, Connecticut  06520-8028
Lee Cancer Care of Lee Memorial Health System Fort Myers, Florida  33901
Broward General Medical Center Cancer Center Ft. Lauderdale, Florida  33316
University of Florida Shands Cancer Center Gainesville, Florida  32610-0232
Baptist-South Miami Regional Cancer Program Miami, Florida  33176
Nemours Children's Clinic - Orlando Orlando, Florida  32806
Florida Hospital Cancer Institute at Florida Hospital Orlando Orlando, Florida  32803-1273
St. Joseph's Cancer Institute at St. Joseph's Hospital Tampa, Florida  33607
Kaplan Cancer Center at St. Mary's Medical Center West Palm Beach, Florida  33407
St. Vincent Indianapolis Hospital Indianapolis, Indiana  46260
Blank Children's Hospital Des Moines, Iowa  50309
Ochsner Cancer Institute at Ochsner Clinic Foundation New Orleans, Louisiana  70121
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital Baltimore, Maryland  21215
Floating Hospital for Children at Tufts - New England Medical Center Boston, Massachusetts  02111
Breslin Cancer Center at Ingham Regional Medical Center Lansing, Michigan  48910
Hackensack University Medical Center Cancer Center Hackensack, New Jersey  07601
Albert Einstein Cancer Center at Albert Einstein College of Medicine Bronx, New York  10461
NYU Cancer Institute at New York University Medical Center New York, New York  10016
Mount Sinai Medical Center New York, New York  10029
Stony Brook University Cancer Center Stony Brook, New York  11794-8174
SUNY Upstate Medical University Hospital Syracuse, New York  13210
Mission Hospitals - Memorial Campus Asheville, North Carolina  28801
Presbyterian Cancer Center at Presbyterian Hospital Charlotte, North Carolina  28233-3549
Wake Forest University Comprehensive Cancer Center Winston-Salem, North Carolina  27157-1096
Cincinnati Children's Hospital Medical Center Cincinnati, Ohio  45229-3039
Rainbow Babies and Children's Hospital Cleveland, Ohio  44106-5000
Toledo Hospital Toledo, Ohio  43606
Rhode Island Hospital Comprehensive Cancer Center Providence, Rhode Island  02903
Hollings Cancer Center at Medical University of South Carolina Charleston, South Carolina  29425
Texas Tech University Health Sciences Center School of Medicine - Amarillo Amarillo, Texas  79106
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas Dallas, Texas  75390
Baylor University Medical Center - Houston Houston, Texas  77030-2399
Methodist Children's Hospital of South Texas San Antonio, Texas  78229-3993
Primary Children's Medical Center Salt Lake City, Utah  84113-1100
Naval Medical Center - Portsmouth Portsmouth, Virginia  23708-2197
Providence Cancer Center at Sacred Heart Medical Center Spokane, Washington  99220-2555
St. Vincent Hospital Regional Cancer Center Green Bay, Wisconsin  54307-3508
Saint Peter's University Hospital New Brunswick, New Jersey  08901-1780
James P. Wilmot Cancer Center at University of Rochester Medical Center Rochester, New York  14642
William Beaumont Hospital - Royal Oak Campus Royal Oak, Michigan  48073
David C. Pratt Cancer Center at St. John's Mercy St. Louis, Missouri  63141
Greenebaum Cancer Center at University of Maryland Medical Center Baltimore, Maryland  21201
UNMC Eppley Cancer Center at the University of Nebraska Medical Center Omaha, Nebraska  68198-7680
Memorial Cancer Institute at Memorial Regional Hospital Hollywood, Florida  33021
New York Weill Cornell Cancer Center at Cornell University New York, New York  10021
University of South Alabama Mitchell Cancer Institute Mobile, Alabama  36604
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center Los Angeles, California  90048-1865
Childrens Hospital Los Angeles Los Angeles, California  90027
Children's Hospital and Research Center Oakland Oakland, California  94609
Lucile Packard Children's Hospital at Stanford University Medical Center Palo Alto, California  95798
Rady Children's Hospital - San Diego San Diego, California  92123-4282
UCSF Helen Diller Family Comprehensive Cancer Center San Francisco, California  94115
Alfred I. duPont Hospital for Children Wilmington, Delaware  19803
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center Washington, District of Columbia  20007
M.D. Anderson Cancer Center at Orlando Orlando, Florida  32806
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus Atlanta, Georgia  30322
MBCCOP - Medical College of Georgia Cancer Center Augusta, Georgia  30912-3730
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center Savannah, Georgia  31403-3089
Mountain States Tumor Institute at St. Luke's Regional Medical Center Boise, Idaho  83712-6297
University of Illinois Cancer Center Chicago, Illinois  60612-7243
Keyser Family Cancer Center at Advocate Hope Children's Hospital Oak Lawn, Illinois  60453
Advocate Lutheran General Cancer Care Center Park Ridge, Illinois  60068-1174
Simmons Cooper Cancer Institute Springfield, Illinois  62794-9677
Lucille P. Markey Cancer Center at University of Kentucky Lexington, Kentucky  40536-0093
Tulane Cancer Center Office of Clinical Research Alexandria, Louisiana  71315-3198
CancerCare of Maine at Eastern Maine Medical Center Bangor, Maine  04401
Maine Children's Cancer Program at Barbara Bush Children's Hospital Scarborough, Maine  04074-9308
C.S. Mott Children's Hospital at University of Michigan Medical Center Ann Arbor, Michigan  48109-0286
Masonic Cancer Center at University of Minnesota Minneapolis, Minnesota  55455
Children's Hospitals and Clinics of Minnesota - Minneapolis Minneapolis, Minnesota  55404
University of Mississippi Cancer Clinic Jackson, Mississippi  39216-4505
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis St. Louis, Missouri  63110
Children's Hospital Omaha, Nebraska  68114-4113
CCOP - Nevada Cancer Research Foundation Las Vegas, Nevada  89109-2306
St. Barnabas Medical Center Cancer Center Livingston, New Jersey  07039
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School New Brunswick, New Jersey  08903
University of New Mexico Cancer Center Albuquerque, New Mexico  87131-5636
Albany Medical Center Hospital Albany, New York  12208-3419
Akron Children's Hospital Akron, Ohio  44308-1062
Nationwide Children's Hospital Columbus, Ohio  43205-2696
Dayton Children's - Dayton Dayton, Ohio  45404-1815
Oklahoma University Cancer Institute Oklahoma City, Oklahoma  73104
Knight Cancer Institute at Oregon Health and Science University Portland, Oregon  97239-3098
Geisinger Cancer Institute at Geisinger Health Danville, Pennsylvania  17822-0001
Penn State Children's Hospital Hershey, Pennsylvania  17033-0850
Children's Hospital of Pittsburgh of UPMC Pittsburgh, Pennsylvania  15213
Dell Children's Medical Center of Central Texas Austin, Texas  78723
M. D. Anderson Cancer Center at University of Texas Houston, Texas  77030-4009
Virginia Commonwealth University Massey Cancer Center Richmond, Virginia  23298-0037
Carilion Medical Center for Children at Roanoke Community Hospital Roanoke, Virginia  24014
Madigan Army Medical Center - Tacoma Tacoma, Washington  98431
Mary Bridge Children's Hospital and Health Center - Tacoma Tacoma, Washington  98405
West Virginia University Health Sciences Center - Charleston Charleston, West Virginia  25302
Riley's Children Cancer Center at Riley Hospital for Children Indianapolis, Indiana  46202-5225
University of Virginia Cancer Center Charlottesville, Virginia  22908
Massachusetts General Hospital Boston, Massachusetts  02114-2617
University of Miami Sylvester Comprehensive Cancer Center - Miami Miami, Florida  33136
Leo W. Jenkins Cancer Center at ECU Medical School Greenville, North Carolina  27834
Lehigh Valley Hospital - Muhlenberg Bethlehem, Pennsylvania  18017
Duke Cancer Institute Durham, North Carolina  27710
T.C. Thompson Children's Hospital Chattanooga, Tennessee  37403
Connecticut Children's Medical Center Hartford, Connecticut  06106
Children's Hospital Colorado Center for Cancer and Blood Disorders Aurora, Colorado  80045
Nemours Children's Clinic - Pensacola Pensacola, Florida  32504
Helen DeVos Children's Hospital at Spectrum Health Grand Rapids, Michigan  49503
Mercy Children's Hospital Toledo, Ohio  43608
Legacy Emanuel Children's Hospital Portland, Oregon  97227
BI-LO Charities Children's Cancer Center Greenville, South Carolina  29605
Mattel Children's Hospital at UCLA Los Angeles, California  90095
Children's Hospital of Alabama at University of Alabama at Birmingham Birmingham, Alabama  35233