Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00482352
Other study ID # AALL03B1
Secondary ID NCI-2009-00303CO
Status Completed
Phase
First received
Last updated
Start date December 2003
Est. completion date June 30, 2023

Study information

Verified date August 2023
Source Children's Oncology Group
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Other known NCT identifiers
  • NCT00228722

Recruitment information / eligibility

Status Completed
Enrollment 11196
Est. completion date June 30, 2023
Est. primary completion date April 2012
Accepts healthy volunteers No
Gender All
Age group 1 Year to 30 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms

  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Untreated Adult Acute Lymphoblastic Leukemia
  • Untreated Childhood Acute Lymphoblastic Leukemia

Intervention

Other:
laboratory biomarker analysis
Correlative studies

Locations

Country Name City State
Australia Royal Brisbane and Women's Hospital Herston Queensland
Australia Women's and Children's Hospital-Adelaide North Adelaide South Australia
Australia Royal Children's Hospital Parkville Victoria
Australia Princess Margaret Hospital for Children Perth Western Australia
Australia The Children's Hospital at Westmead Westmead New South Wales
Canada Alberta Children's Hospital Calgary Alberta
Canada University of Alberta Hospital Edmonton Alberta
Canada IWK Health Centre Halifax Nova Scotia
Canada Cancer Centre of Southeastern Ontario at Kingston General Hospital Kingston Ontario
Canada Children's Hospital London Ontario
Canada The Montreal Children's Hospital of the MUHC Montreal Quebec
Canada Children's Hospital of Eastern Ontario Ottawa Ontario
Canada Allan Blair Cancer Centre Regina Saskatchewan
Canada Janeway Child Health Centre Saint John's Newfoundland and Labrador
Canada Saskatoon Cancer Centre Saskatoon Saskatchewan
Canada Hospital for Sick Children Toronto Ontario
Canada British Columbia Children's Hospital Vancouver British Columbia
Canada CancerCare Manitoba Winnipeg Manitoba
New Zealand Christchurch Hospital Christchurch
New Zealand Starship Children's Hospital Grafton Auckland
Puerto Rico San Jorge Children's Hospital Santurce
Switzerland Swiss Pediatric Oncology Group - Bern Bern
Switzerland Swiss Pediatric Oncology Group - Geneva Geneva
Switzerland Swiss Pediatric Oncology Group - Lausanne Lausanne
United States Children's Hospital Medical Center of Akron Akron Ohio
United States Albany Medical Center Albany New York
United States University of New Mexico Cancer Center Albuquerque New Mexico
United States Texas Tech University Health Science Center-Amarillo Amarillo Texas
United States C S Mott Children's Hospital Ann Arbor Michigan
United States Mission Hospitals Asheville North Carolina
United States Children's Healthcare of Atlanta - Egleston Atlanta Georgia
United States Georgia Regents University Augusta Georgia
United States Children's Hospital Colorado Aurora Colorado
United States Dell Children's Medical Center of Central Texas Austin Texas
United States Johns Hopkins University Baltimore Maryland
United States Sinai Hospital of Baltimore Baltimore Maryland
United States University of Maryland Greenebaum Cancer Center Baltimore Maryland
United States Eastern Maine Medical Center Bangor Maine
United States Walter Reed National Military Medical Center Bethesda Maryland
United States Lehigh Valley Hospital - Muhlenberg Bethlehem Pennsylvania
United States University of Alabama at Birmingham Birmingham Alabama
United States Saint Luke's Mountain States Tumor Institute Boise Idaho
United States Massachusetts General Hospital Cancer Center Boston Massachusetts
United States Montefiore Medical Center Bronx New York
United States Brooklyn Hospital Center Brooklyn New York
United States Roswell Park Cancer Institute Buffalo New York
United States University of Vermont Burlington Vermont
United States University of North Carolina Chapel Hill North Carolina
United States Medical University of South Carolina Charleston South Carolina
United States West Virginia University Charleston Charleston West Virginia
United States Carolinas Medical Center Charlotte North Carolina
United States Presbyterian Hospital Charlotte North Carolina
United States University of Virginia Charlottesville Virginia
United States T C Thompson Children's Hospital Chattanooga Tennessee
United States Lurie Children's Hospital-Chicago Chicago Illinois
United States University of Chicago Chicago Illinois
United States University of Illinois Chicago Illinois
United States Cincinnati Children's Hospital Medical Center Cincinnati Ohio
United States Cleveland Clinic Foundation Cleveland Ohio
United States Rainbow Babies and Childrens Hospital Cleveland Ohio
United States Palmetto Health Richland Columbia South Carolina
United States University of Missouri-Columbia Columbia Missouri
United States Nationwide Children's Hospital Columbus Ohio
United States Driscoll Children's Hospital Corpus Christi Texas
United States Medical City Dallas Hospital Dallas Texas
United States University of Texas Southwestern Medical Center Dallas Texas
United States Geisinger Medical Center Danville Pennsylvania
United States The Children's Medical Center of Dayton Dayton Ohio
United States Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center Denver Colorado
United States Blank Children's Hospital Des Moines Iowa
United States Saint John Hospital and Medical Center Detroit Michigan
United States Wayne State University-Karmanos Cancer Institute Detroit Michigan
United States Southern California Permanente Medical Group Downey California
United States City of Hope Medical Center Duarte California
United States Duke University Medical Center Durham North Carolina
United States Inova Fairfax Hospital Falls Church Virginia
United States Sanford Medical Center-Fargo Fargo North Dakota
United States Hurley Medical Center Flint Michigan
United States Broward Health Medical Center Fort Lauderdale Florida
United States Lee Memorial Health System Fort Myers Florida
United States Cook Children's Medical Center Fort Worth Texas
United States University of Florida Gainesville Florida
United States Helen DeVos Children's Hospital at Spectrum Health Grand Rapids Michigan
United States Saint Vincent Hospital Green Bay Wisconsin
United States East Carolina University Greenville North Carolina
United States Greenville Cancer Treatment Center Greenville South Carolina
United States Hackensack University Medical Center Hackensack New Jersey
United States Connecticut Children's Medical Center Hartford Connecticut
United States Penn State Hershey Children's Hospital Hershey Pennsylvania
United States Memorial Healthcare System - Joe DiMaggio Children's Hospital Hollywood Florida
United States Tripler Army Medical Center Honolulu Hawaii
United States University of Hawaii Honolulu Hawaii
United States Baylor College of Medicine Houston Texas
United States M D Anderson Cancer Center Houston Texas
United States Indiana University Medical Center Indianapolis Indiana
United States Saint Vincent Hospital and Health Services Indianapolis Indiana
United States University of Iowa Hospitals and Clinics Iowa City Iowa
United States University of Mississippi Medical Center Jackson Mississippi
United States Nemours Children's Clinic - Jacksonville Jacksonville Florida
United States Kalamazoo Center for Medical Studies Kalamazoo Michigan
United States The Childrens Mercy Hospital Kansas City Missouri
United States East Tennessee Childrens Hospital Knoxville Tennessee
United States Michigan State University - Breslin Cancer Center Lansing Michigan
United States Nevada Cancer Research Foundation CCOP Las Vegas Nevada
United States Dartmouth Hitchcock Medical Center Lebanon New Hampshire
United States University of Kentucky Lexington Kentucky
United States University of Arkansas for Medical Sciences Little Rock Arkansas
United States Loma Linda University Medical Center Loma Linda California
United States Miller Children's Hospital Long Beach California
United States Cedars-Sinai Medical Center Los Angeles California
United States Children's Hospital Los Angeles Los Angeles California
United States David Geffen School of Medicine at UCLA Los Angeles California
United States Kosair Children's Hospital Louisville Kentucky
United States Covenant Children's Hospital Lubbock Texas
United States Children's Hospital Central California Madera California
United States University of Wisconsin Hospital and Clinics Madison Wisconsin
United States Marshfield Clinic Marshfield Wisconsin
United States Loyola University Medical Center Maywood Illinois
United States Baptist Hospital of Miami Miami Florida
United States Miami Children's Hospital Miami Florida
United States University of Miami Miller School of Medicine-Sylvester Cancer Center Miami Florida
United States Midwest Children's Cancer Center Milwaukee Wisconsin
United States Winthrop University Hospital Mineola New York
United States Children's Hospitals and Clinics of Minnesota - Minneapolis Minneapolis Minnesota
United States University of Minnesota Medical Center-Fairview Minneapolis Minnesota
United States University of South Alabama Mobile Alabama
United States Vanderbilt-Ingram Cancer Center Nashville Tennessee
United States Saint Peter's University Hospital New Brunswick New Jersey
United States UMDNJ - Robert Wood Johnson University Hospital New Brunswick New Jersey
United States Yale University New Haven Connecticut
United States The Steven and Alexandra Cohen Children's Medical Center of New York New Hyde Park New York
United States Children's Hospital-Main Campus New Orleans Louisiana
United States Tulane University Health Sciences Center New Orleans Louisiana
United States Memorial Sloan-Kettering Cancer Center New York New York
United States Mount Sinai Medical Center New York New York
United States New York University Langone Medical Center New York New York
United States Weill Medical College of Cornell University New York New York
United States Newark Beth Israel Medical Center Newark New Jersey
United States Childrens Hospital-King's Daughters Norfolk Virginia
United States Advocate Children's Hospital-Oak Lawn Oak Lawn Illinois
United States Children's Hospital and Research Center at Oakland Oakland California
United States Kaiser Permanente-Oakland Oakland California
United States University of Oklahoma Health Sciences Center Oklahoma City Oklahoma
United States Children's Hospital and Medical Center of Omaha Omaha Nebraska
United States University of Nebraska Medical Center Omaha Nebraska
United States Childrens Hospital of Orange County Orange California
United States Florida Hospital Orlando Florida
United States Nemours Childrens Clinic - Orlando Orlando Florida
United States UF Cancer Center at Orlando Health Orlando Florida
United States Lucile Packard Children's Hospital Stanford University Palo Alto California
United States Advocate Lutheran General Hospital. Park Ridge Illinois
United States Saint Joseph's Regional Medical Center Paterson New Jersey
United States Nemours Children's Clinic - Pensacola Pensacola Florida
United States Saint Jude Midwest Affiliate Peoria Illinois
United States Children's Hospital of Philadelphia Philadelphia Pennsylvania
United States Saint Christopher's Hospital for Children Philadelphia Pennsylvania
United States Phoenix Childrens Hospital Phoenix Arizona
United States Children's Hospital of Pittsburgh of UPMC Pittsburgh Pennsylvania
United States Legacy Emanuel Hospital and Health Center Portland Oregon
United States Oregon Health and Science University Portland Oregon
United States Naval Medical Center - Portsmouth Portsmouth Virginia
United States Rhode Island Hospital Providence Rhode Island
United States Virginia Commonwealth University Richmond Virginia
United States Carilion Clinic Children's Hospital Roanoke Virginia
United States Mayo Clinic Rochester Minnesota
United States University of Rochester Rochester New York
United States William Beaumont Hospital-Royal Oak Royal Oak Michigan
United States UC Davis Comprehensive Cancer Center Sacramento California
United States Cardinal Glennon Children's Medical Center Saint Louis Missouri
United States Washington University School of Medicine Saint Louis Missouri
United States All Children's Hospital Saint Petersburg Florida
United States Primary Children's Hospital Salt Lake City Utah
United States Methodist Children's Hospital of South Texas San Antonio Texas
United States University of Texas Health Science Center at San Antonio San Antonio Texas
United States Rady Children's Hospital - San Diego San Diego California
United States University of California San Francisco Medical Center-Parnassus San Francisco California
United States Memorial Health University Medical Center Savannah Georgia
United States Maine Children's Cancer Program Scarborough Maine
United States Seattle Children's Hospital Seattle Washington
United States Providence Sacred Heart Medical Center and Children's Hospital Spokane Washington
United States Baystate Medical Center Springfield Massachusetts
United States Southern Illinois University Springfield Illinois
United States Stony Brook University Medical Center Stony Brook New York
United States Overlook Hospital Summit New Jersey
United States State University of New York Upstate Medical University Syracuse New York
United States Madigan Army Medical Center Tacoma Washington
United States Mary Bridge Children's Hospital and Health Center Tacoma Washington
United States Saint Joseph Children's Hospital of Tampa Tampa Florida
United States Scott and White Memorial Hospital Temple Texas
United States Mercy Children's Hospital Toledo Ohio
United States The Toledo Hospital/Toledo Children's Hospital Toledo Ohio
United States University of Arizona Health Sciences Center Tucson Arizona
United States Natalie W Bryant Cancer Center Tulsa Oklahoma
United States Ny Cancer% Valhalla New York
United States Children's National Medical Center Washington District of Columbia
United States Lombardi Comprehensive Cancer Center at Georgetown University Washington District of Columbia
United States Saint Mary's Hospital West Palm Beach Florida
United States Alfred I duPont Hospital for Children Wilmington Delaware
United States Wake Forest University Health Sciences Winston-Salem North Carolina
United States University of Massachusetts Medical School Worcester Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Children's Oncology Group National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Australia,  Canada,  New Zealand,  Puerto Rico,  Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary Development of a classification database for correlative studies Up to 5 years
Primary Development of a central reference guide for all required and research only ALL studies Up to 5 years
Primary Development of a leukemia and germline specimen bank for current and future research Up to 5 years
See also
  Status Clinical Trial Phase
Terminated NCT01564277 - Rasburicase and Allopurinol in Treating Patients With Hematologic Malignancies Phase 2
Terminated NCT00387426 - Sunitinib in Treating Patients With Idiopathic Myelofibrosis Phase 2
Completed NCT00078858 - Mycophenolate Mofetil and Cyclosporine in Reducing Graft-Versus-Host Disease in Patients With Hematologic Malignancies or Metastatic Kidney Cancer Undergoing Donor Stem Cell Transplant Phase 1/Phase 2
Active, not recruiting NCT01424982 - Combination Chemotherapy and Ponatinib Hydrochloride in Treating Patients With Acute Lymphoblastic Leukemia Phase 2
Completed NCT00608361 - Dasatinib in Treating Patients With Solid Tumors or Lymphomas That Are Metastatic or Cannot Be Removed By Surgery Phase 1
Completed NCT00459212 - GTI-2040 in Treating Patients With Relapsed, Refractory, or High-Risk Acute Leukemia, High-Grade Myelodysplastic Syndromes, or Refractory or Blastic Phase Chronic Myelogenous Leukemia Phase 1
Completed NCT00061945 - Alemtuzumab and Combination Chemotherapy in Treating Patients With Untreated Acute Lymphoblastic Leukemia Phase 1/Phase 2
Completed NCT02122081 - Organ-Sparing Marrow-Targeted Irradiation Before Stem Cell Transplant in Treating Patients With High-Risk Hematologic Malignancies Phase 1
Completed NCT01869777 - Bioelectrical Impedance Measurement for Predicting Treatment Outcome in Patients With Newly Diagnosed Acute Leukemia N/A
Completed NCT01273766 - Deferasirox in Treating Iron Overload Caused By Blood Transfusions in Patients With Hematologic Malignancies Phase 2
Completed NCT00278330 - Flavopiridol and Vorinostat in Treating Patients With Relapsed or Refractory Acute Leukemia or Chronic Myelogenous Leukemia or Refractory Anemia Phase 1
Recruiting NCT01406756 - Combination Chemotherapy in Treating Young Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia Phase 3
Completed NCT00860574 - Treosulfan, Fludarabine Phosphate, and Total-Body Irradiation Before Donor Stem Cell Transplant in Treating Patients With High-Risk Acute Myeloid Leukemia, Myelodysplastic Syndrome, Acute Lymphoblastic Leukemia Phase 2
Completed NCT00275080 - Vorinostat and Decitabine in Treating Patients With Advanced Solid Tumors or Relapsed or Refractory Non-Hodgkin's Lymphoma, Acute Myeloid Leukemia, Acute Lymphocytic Leukemia, or Chronic Myelogenous Leukemia Phase 1
Completed NCT00016016 - Flavopiridol, Cytarabine, and Mitoxantrone in Treating Patients With Acute Leukemia Phase 1/Phase 2
Withdrawn NCT01670084 - Nilotinib and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia or Blastic Phase Chronic Myelogenous Leukemia Phase 2
Completed NCT00301938 - 7-Hydroxystaurosporine and Perifosine in Treating Patients With Relapsed or Refractory Acute Leukemia, Chronic Myelogenous Leukemia or High Risk Myelodysplastic Syndromes Phase 1
Completed NCT00014235 - Fludarabine Phosphate and Total-Body Radiation Followed by Donor Peripheral Blood Stem Cell Transplant and Immunosuppression in Treating Patients With Hematologic Malignancies N/A
Completed NCT02293109 - Carfilzomib and Hyper-CVAD in Treating Patients With Newly Diagnosed Acute Lymphoblastic Leukemia or Lymphoma Phase 1
Terminated NCT01044745 - Rituximab in Preventing Acute Graft-Versus-Host Disease in a Donor Stem Cell Transplant for Hematologic Cancer Phase 2