Risk-Group Classification of Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00482352
First received: June 4, 2007
Last updated: February 13, 2014
Last verified: February 2014
  Purpose

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 Intervention
Untreated Adult Acute Lymphoblastic Leukemia
Untreated Childhood Acute Lymphoblastic Leukemia
Other: laboratory biomarker analysis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Classification Of Acute Lymphoblastic Leukemia

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

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) [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Development of a classification database for correlative studies [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Development of a central reference guide for all required and research only ALL studies [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Development of a leukemia and germline specimen bank for current and future research [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

marrow and blood samples


Enrollment: 11196
Study Start Date: December 2003
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

Detailed Description:

OBJECTIVES:

I. 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.

II. Provide an administrative base to capture classification data for correlative studies accompanying current Children's Oncology Group (COG) ALL treatment clinical trials.

III. Provide a central reference guide for all required and research only ALL studies that will be conducted at local and reference laboratories.

IV. 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.

  Eligibility

Ages Eligible for Study:   1 Year to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Any patient with newly diagnosed acute lymphoblastic leukemia meeting other criteria.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00482352

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
University of South Alabama
Mobile, Alabama, United States, 36604
United States, Arizona
Phoenix Childrens Hospital
Phoenix, Arizona, United States, 85016
University of Arizona Health Sciences Center
Tucson, Arizona, United States, 85724
United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
Southern California Permanente Medical Group
Downey, California, United States, 90242
City of Hope Medical Center
Duarte, California, United States, 91010
Loma Linda University Medical Center
Loma Linda, California, United States, 92354
Miller Children's Hospital
Long Beach, California, United States, 90806
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
David Geffen School of Medicine at UCLA
Los Angeles, California, United States, 90095
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
Children's Hospital Central California
Madera, California, United States, 93636-8762
Children's Hospital and Research Center at Oakland
Oakland, California, United States, 94609-1809
Kaiser Permanente-Oakland
Oakland, California, United States, 94611
Childrens Hospital of Orange County
Orange, California, United States, 92868-3874
Lucile Packard Children's Hospital Stanford University
Palo Alto, California, United States, 94304
UC Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
Rady Children's Hospital - San Diego
San Diego, California, United States, 92123
University of California San Francisco Medical Center-Parnassus
San Francisco, California, United States, 94143
United States, Colorado
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
Denver, Colorado, United States, 80218
United States, Connecticut
Connecticut Children's Medical Center
Hartford, Connecticut, United States, 06106
Yale University
New Haven, Connecticut, United States, 06520
United States, Delaware
Alfred I duPont Hospital for Children
Wilmington, Delaware, United States, 19803
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010
Lombardi Comprehensive Cancer Center at Georgetown University
Washington, District of Columbia, United States, 20057
United States, Florida
Broward Health Medical Center
Fort Lauderdale, Florida, United States, 33316
Lee Memorial Health System
Fort Myers, Florida, United States, 33901
University of Florida
Gainesville, Florida, United States, 32610
Memorial Healthcare System - Joe DiMaggio Children's Hospital
Hollywood, Florida, United States, 33021
Nemours Children's Clinic - Jacksonville
Jacksonville, Florida, United States, 32207-8426
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States, 33136
Miami Children's Hospital
Miami, Florida, United States, 33155
Baptist Hospital of Miami
Miami, Florida, United States, 33176
UF Cancer Center at Orlando Health
Orlando, Florida, United States, 32806
Florida Hospital
Orlando, Florida, United States, 32803
Nemours Childrens Clinic - Orlando
Orlando, Florida, United States, 32806
Nemours Children's Clinic - Pensacola
Pensacola, Florida, United States, 32504
All Children's Hospital
Saint Petersburg, Florida, United States, 33701
Saint Joseph Children's Hospital of Tampa
Tampa, Florida, United States, 33607
Saint Mary's Hospital
West Palm Beach, Florida, United States, 33407
United States, Georgia
Children's Healthcare of Atlanta - Egleston
Atlanta, Georgia, United States, 30322
Georgia Regents University
Augusta, Georgia, United States, 30912
Memorial Health University Medical Center
Savannah, Georgia, United States, 31403
United States, Hawaii
Tripler Army Medical Center
Honolulu, Hawaii, United States, 96859
University of Hawaii
Honolulu, Hawaii, United States, 96813
United States, Idaho
Saint Luke's Mountain States Tumor Institute
Boise, Idaho, United States, 83712
United States, Illinois
Lurie Children's Hospital-Chicago
Chicago, Illinois, United States, 60614
University of Chicago
Chicago, Illinois, United States, 60637
University of Illinois
Chicago, Illinois, United States, 60612
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Advocate Children's Hospital-Oak Lawn
Oak Lawn, Illinois, United States, 60453
Advocate Lutheran General Hospital.
Park Ridge, Illinois, United States, 60068
Saint Jude Midwest Affiliate
Peoria, Illinois, United States, 61602
Southern Illinois University
Springfield, Illinois, United States, 62702
United States, Indiana
Saint Vincent Hospital and Health Services
Indianapolis, Indiana, United States, 46260
Indiana University Medical Center
Indianapolis, Indiana, United States, 46202
United States, Iowa
Blank Children's Hospital
Des Moines, Iowa, United States, 50309
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40536
Kosair Children's Hospital
Louisville, Kentucky, United States, 40202
United States, Louisiana
Children's Hospital-Main Campus
New Orleans, Louisiana, United States, 70118
Tulane University Health Sciences Center
New Orleans, Louisiana, United States, 70112
United States, Maine
Eastern Maine Medical Center
Bangor, Maine, United States, 04401
Maine Children's Cancer Program
Scarborough, Maine, United States, 04074
United States, Maryland
Sinai Hospital of Baltimore
Baltimore, Maryland, United States, 21215
Johns Hopkins University
Baltimore, Maryland, United States, 21287
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, United States, 21201-1595
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889-5600
United States, Massachusetts
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
Baystate Medical Center
Springfield, Massachusetts, United States, 01199
University of Massachusetts Medical School
Worcester, Massachusetts, United States, 01655
United States, Michigan
C S Mott Children's Hospital
Ann Arbor, Michigan, United States, 48109
Wayne State University-Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Saint John Hospital and Medical Center
Detroit, Michigan, United States, 48236
Hurley Medical Center
Flint, Michigan, United States, 48502
Helen DeVos Children's Hospital at Spectrum Health
Grand Rapids, Michigan, United States, 49503
Kalamazoo Center for Medical Studies
Kalamazoo, Michigan, United States, 49008
Michigan State University - Breslin Cancer Center
Lansing, Michigan, United States, 48910
William Beaumont Hospital-Royal Oak
Royal Oak, Michigan, United States, 48073
United States, Minnesota
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis, Minnesota, United States, 55404
University of Minnesota Medical Center-Fairview
Minneapolis, Minnesota, United States, 55455
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
United States, Missouri
University of Missouri-Columbia
Columbia, Missouri, United States, 65212
The Childrens Mercy Hospital
Kansas City, Missouri, United States, 64108
Cardinal Glennon Children's Medical Center
Saint Louis, Missouri, United States, 63104
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, Nebraska
Children's Hospital and Medical Center of Omaha
Omaha, Nebraska, United States, 68114
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
United States, Nevada
Nevada Cancer Research Foundation CCOP
Las Vegas, Nevada, United States, 89106
United States, New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Saint Peter's University Hospital
New Brunswick, New Jersey, United States, 08901
UMDNJ - Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States, 08903
Newark Beth Israel Medical Center
Newark, New Jersey, United States, 07112
Saint Joseph's Regional Medical Center
Paterson, New Jersey, United States, 07503
Overlook Hospital
Summit, New Jersey, United States, 07902
United States, New Mexico
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87106
United States, New York
Albany Medical Center
Albany, New York, United States, 12208
Montefiore Medical Center
Bronx, New York, United States, 10467-2490
Brooklyn Hospital Center
Brooklyn, New York, United States, 11201
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Winthrop University Hospital
Mineola, New York, United States, 11501
The Steven and Alexandra Cohen Children's Medical Center of New York
New Hyde Park, New York, United States, 11040
Weill Medical College of Cornell University
New York, New York, United States, 10065
New York University Langone Medical Center
New York, New York, United States, 10016
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Mount Sinai Medical Center
New York, New York, United States, 10029
University of Rochester
Rochester, New York, United States, 14642
Stony Brook University Medical Center
Stony Brook, New York, United States, 11794
State University of New York Upstate Medical University
Syracuse, New York, United States, 13210
Ny Cancer%
Valhalla, New York, United States, 10595
United States, North Carolina
Mission Hospitals
Asheville, North Carolina, United States, 28801
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Carolinas Medical Center
Charlotte, North Carolina, United States, 28203
Presbyterian Hospital
Charlotte, North Carolina, United States, 28204
Duke University Medical Center
Durham, North Carolina, United States, 27710
East Carolina University
Greenville, North Carolina, United States, 27858
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
United States, North Dakota
Sanford Medical Center-Fargo
Fargo, North Dakota, United States, 58122
United States, Ohio
Children's Hospital Medical Center of Akron
Akron, Ohio, United States, 44308
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Rainbow Babies and Childrens Hospital
Cleveland, Ohio, United States, 44106
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
The Children's Medical Center of Dayton
Dayton, Ohio, United States, 45404
Mercy Children's Hospital
Toledo, Ohio, United States, 43608
The Toledo Hospital/Toledo Children's Hospital
Toledo, Ohio, United States, 43606
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Natalie W Bryant Cancer Center
Tulsa, Oklahoma, United States, 74136
United States, Oregon
Legacy Emanuel Hospital and Health Center
Portland, Oregon, United States, 97227
Oregon Health and Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania, United States, 18017
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822-2001
Penn State Hershey Children's Hospital
Hershey, Pennsylvania, United States, 17033
Saint Christopher's Hospital for Children
Philadelphia, Pennsylvania, United States, 19134
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States, 15224
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Palmetto Health Richland
Columbia, South Carolina, United States, 29203
Greenville Cancer Treatment Center
Greenville, South Carolina, United States, 29605
United States, Tennessee
T C Thompson Children's Hospital
Chattanooga, Tennessee, United States, 37403
East Tennessee Childrens Hospital
Knoxville, Tennessee, United States, 37916
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232
United States, Texas
Texas Tech University Health Science Center-Amarillo
Amarillo, Texas, United States, 79106
Dell Children's Medical Center of Central Texas
Austin, Texas, United States, 78723
Driscoll Children's Hospital
Corpus Christi, Texas, United States, 78411
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Medical City Dallas Hospital
Dallas, Texas, United States, 75230
Cook Children's Medical Center
Fort Worth, Texas, United States, 76104
Baylor College of Medicine
Houston, Texas, United States, 77030
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Covenant Children's Hospital
Lubbock, Texas, United States, 79410
Methodist Children's Hospital of South Texas
San Antonio, Texas, United States, 78229
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229-3900
Scott and White Memorial Hospital
Temple, Texas, United States, 76508
United States, Utah
Primary Children's Hospital
Salt Lake City, Utah, United States, 84113
United States, Vermont
University of Vermont
Burlington, Vermont, United States, 05401
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Inova Fairfax Hospital
Falls Church, Virginia, United States, 22042
Childrens Hospital-King's Daughters
Norfolk, Virginia, United States, 23507
Naval Medical Center - Portsmouth
Portsmouth, Virginia, United States, 23708-2197
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Carilion Clinic Children's Hospital
Roanoke, Virginia, United States, 24014
United States, Washington
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Providence Sacred Heart Medical Center and Children's Hospital
Spokane, Washington, United States, 99204
Mary Bridge Children's Hospital and Health Center
Tacoma, Washington, United States, 98405
Madigan Army Medical Center
Tacoma, Washington, United States, 98431
United States, West Virginia
West Virginia University Charleston
Charleston, West Virginia, United States, 25304
United States, Wisconsin
Saint Vincent Hospital
Green Bay, Wisconsin, United States, 54301
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
Marshfield Clinic
Marshfield, Wisconsin, United States, 54449
Midwest Children's Cancer Center
Milwaukee, Wisconsin, United States, 53226
Australia, New South Wales
The Children's Hospital at Westmead
Westmead, New South Wales, Australia, 2145
Australia, Queensland
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia, 4029
Australia, South Australia
Women's and Children's Hospital-Adelaide
North Adelaide, South Australia, Australia, 5006
Australia, Victoria
Royal Children's Hospital
Parkville, Victoria, Australia, 3052
Australia, Western Australia
Princess Margaret Hospital for Children
Perth, Western Australia, Australia, 6008
Canada, Alberta
Alberta Children's Hospital
Calgary, Alberta, Canada, T3B 6A8
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7
Canada, British Columbia
British Columbia Children's Hospital
Vancouver, British Columbia, Canada, V6H 3V4
Canada, Manitoba
CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, Newfoundland and Labrador
Janeway Child Health Centre
Saint John's, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Nova Scotia
IWK Health Centre
Halifax, Nova Scotia, Canada, B3J 3G9
Canada, Ontario
Cancer Centre of Southeastern Ontario at Kingston General Hospital
Kingston, Ontario, Canada, K7L 5P9
Children's Hospital
London, Ontario, Canada, N6A 5W9
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada, K1H 8L1
Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Canada, Quebec
The Montreal Children's Hospital of the MUHC
Montreal, Quebec, Canada, H3H 1P3
Canada, Saskatchewan
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada, S4T 7T1
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada, S7N 4H4
New Zealand
Starship Children's Hospital
Grafton, Auckland, New Zealand, 1145
Christchurch Hospital
Christchurch, New Zealand, 8011
Puerto Rico
San Jorge Children's Hospital
Santurce, Puerto Rico, 00912
Switzerland
Swiss Pediatric Oncology Group - Bern
Bern, Switzerland, 3010
Swiss Pediatric Oncology Group - Geneva
Geneva, Switzerland, 1205
Swiss Pediatric Oncology Group - Lausanne
Lausanne, Switzerland, 1011
Sponsors and Collaborators
Children's Oncology Group
Investigators
Principal Investigator: Mignon Loh, MD Children's Oncology Group
  More Information

No publications provided

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00482352     History of Changes
Obsolete Identifiers: NCT00228722
Other Study ID Numbers: AALL03B1, NCI-2009-00303, COG-AALL03B1, CDR0000344369, AALL03B1, AALL03B1, U10CA098543
Study First Received: June 4, 2007
Last Updated: February 13, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on October 01, 2014