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Combination Chemotherapy With or Without Bone Marrow Transplantation in Treating Children With Acute Myelogenous Leukemia or Myelodysplastic Syndrome
This study has been completed.
First Received: November 24, 2000   Last Updated: April 18, 2009   History of Changes
Sponsor: Children's Oncology Group
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00002798
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. It is not yet known which treatment regimen is more effective for acute myelogenous leukemia or myelodysplastic syndrome.

PURPOSE: Randomized phase III trial to compare the effectiveness of different chemotherapy regimens with or without bone marrow transplantation in treating children who have acute myelogenous leukemia or myelodysplastic syndrome.


Condition Intervention Phase
Leukemia
Myelodysplastic Syndromes
Biological: aldesleukin
Biological: filgrastim
Drug: asparaginase
Drug: busulfan
Drug: cyclophosphamide
Drug: cytarabine
Drug: daunorubicin hydrochloride
Drug: dexamethasone
Drug: etoposide
Drug: fludarabine phosphate
Drug: idarubicin
Drug: methotrexate
Drug: therapeutic hydrocortisone
Drug: thioguanine
Procedure: allogeneic bone marrow transplantation
Radiation: radiation therapy
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Active Control
Official Title: A PHASE III STUDY IN CHILDREN WITH UNTREATED ACUTE MYELOGENOUS LEUKEMIA (AML) OR MYELODYSPLASTIC SYNDROME (MDS)

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 880
Study Start Date: August 1996
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed previously untreated acute myeloid leukemia (AML) in patients 1 month to 21 years of age

    • Infants under 1 month with progressive disease eligible

      • Supportive care may be given to confirm that the leukemia is not regressing prior to entry
    • No acute promyelocytic leukemia (FAB M3)
    • No acute undifferentiated leukemia (FAB M0)
  • Histochemical verification of AML required by the following stains:

    • Wright or Giemsa
    • Peroxidase
    • PAS
    • Chloroacetate esterase
    • Sudan black
    • Nonspecific esterase (NSE) with and without fluoride (NaF) inhibition
    • Combined NSE/NaF and butyrate inhibition or diagnosis of megakaryoblastic leukemia (FAB M7) should be supported by one of the following:

      • CD41 reactivity
      • Glycoprotein 1b reactivity
      • Factor VIII-related antigen reactivity
      • Platelet peroxidase on electron microscopy
  • The following are also eligible:

    • Myelodysplastic syndromes, including:

      • Refractory anemia (RA) *
      • RA with ringed sideroblasts (RARS) *
      • RA with excess blasts (RAEB)
      • RAEB in transformation (RAEBt)
      • Chronic myelomonocytic leukemia (CMML)
    • AML with monosomy 7
    • Granulocytic sarcoma (chloroma) with or without marrow involvement
    • Mixed lineage leukemia with 2 morphologically defined populations provided the predominant population is myeloid
  • No Downs syndrome
  • No juvenile chronic myelogenous leukemia
  • No Fanconi's anemia
  • No secondary AML NOTE: * RA and RARS may be registered and observed until treatment deemed necessary

PATIENT CHARACTERISTICS:

Age:

  • Under 22

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoeitic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior anticancer chemotherapy

Endocrine therapy:

  • Prior topical or inhaled steroids for nonmalignant conditions allowed

Radiotherapy :

  • No prior anticancer radiotherapy

Surgery:

  • Not specified

Other:

  • No prior antileukemic therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002798

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Locations
United States, Alabama
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States, 35233
University of South Alabama Medical Center
Mobile, Alabama, United States, 36604
United States, Arizona
Arizona Cancer Center
Tucson, Arizona, United States, 85724
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016-7710
United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
Cancer Center and Beckman Research Institute, City of Hope
Duarte, California, United States, 91010-3000
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781
Children's Hospital and Health Center
San Diego, California, United States, 92123-4282
Children's Hospital of Oakland
Oakland, California, United States, 94609-1809
Children's Hospital of Orange County
Orange, California, United States, 92868
David Grant Medical Center
Travis Air Force Base, California, United States, 94535
Jonathan Jaques Children's Cancer Center
Long Beach, California, United States, 90801-1428
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027-0700
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, United States, 95051-5386
Kaiser Permanente Medical Group - San Francisco
San Francisco, California, United States, 94115
Kaiser Permanente-Southern California Permanente Medical Group
San Diego, California, United States, 92120
Loma Linda University Medical Center
Loma Linda, California, United States, 92354
Southern California Permanente Medical Group
Downey, California, United States, 90242
Santa Barbara Cottage Hospital
Santa Barbara, California, United States, 93102
Lucile Packard Children's Hospital at Stanford
Palo Alto, California, United States, 94304
Sutter Cancer Center
Sacramento, California, United States, 95816
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, United States, 94143-0128
University of California Davis Medical Center
Sacramento, California, United States, 95817
Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
University of California San Diego Cancer Center
La Jolla, California, United States, 92103-8447
Children's Hospital Central California
Madera, California, United States, 93638-8762
United States, Colorado
Childhood Hematology/Oncology Associates
Denver, Colorado, United States, 80218
Children's Hospital of Denver
Denver, Colorado, United States, 80218-1088
Presbyterian-St Luke's Medical Center
Denver, Colorado, United States, 80218
United States, Connecticut
University of Connecticut Health Center
Farmington, Connecticut, United States, 06360-7106
Yale Comprehensive Cancer Center
New Haven, Connecticut, United States, 06520-8028
United States, Delaware
Alfred I. Dupont Institute
Wilmington, Delaware, United States, 19899
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010-2970
Lombardi Cancer Center
Washington, District of Columbia, United States, 20007
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307-5000
United States, Florida
Nemours Children's Clinic
Jacksonville, Florida, United States, 32207
Baptist Hospital of Miami
Miami, Florida, United States, 33176-2197
Broward General Medical Center
Fort Lauderdale, Florida, United States, 33316
Children's Hospital of Southwest Florida
Fort Myers, Florida, United States, 33908
Joe DiMaggio Children's Hospital at Memorial
Hollywood, Florida, United States, 33021
Miami Children's Hospital
Miami, Florida, United States, 33155-4069
All Children's Hospital
St. Petersburg, Florida, United States, 33701
Nemours Children's Clinic-Orlando
Orlando, Florida, United States, 32806
Sacred Heart Children's Hospital
Pensacola, Florida, United States, 32504
Shands Hospital and Clinics, University of Florida
Gainesville, Florida, United States, 32610-100277
St. Mary's Hospital
West Palm Beach, Florida, United States, 33407
Florida Hospital Cancer Institute
Orlando, Florida, United States, 32803
University of Miami-Jackson Memorial Hospital
Miami, Florida, United States, 33136
Tampa Children's Hospital
Tampa, Florida, United States, 33677-4227
United States, Georgia
Emory University Hospital - Atlanta
Atlanta, Georgia, United States, 30322
Children's Healthcare of Atlanta - Scottish Rite
Atlanta, Georgia, United States, 30342
Medical Center of Central Georgia
Macon, Georgia, United States, 31201
Medical College of Georgia Comprehensive Cancer Center
Augusta, Georgia, United States, 30912-4000
Memorial Health University Medical Center, Inc.
Savannah, Georgia, United States, 31403-3089
United States, Hawaii
Cancer Research Center of Hawaii
Honolulu, Hawaii, United States, 96813
Tripler Army Medical Center
Honolulu, Hawaii, United States, 96859-5000
United States, Idaho
Mountain States Tumor Institute
Boise, Idaho, United States, 83712
United States, Illinois
Children's Memorial Hospital, Chicago
Chicago, Illinois, United States, 60614
Hope Children's Hospital
Oak Lawn, Illinois, United States, 60453
Lutheran General Hospital
Park Ridge, Illinois, United States, 60068-1174
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60601
Saint Jude Midwest Affiliate
Peoria, Illinois, United States, 61637
Southern Illinois University School of Medicine
Springfield, Illinois, United States, 62794-9658
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, United States, 60612
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
United States, Indiana
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202-5289
St. Vincent Hospital and Health Care Center
Indianapolis, Indiana, United States, 46260
United States, Iowa
Holden Comprehensive Cancer Center
Iowa City, Iowa, United States, 52242-1009
Raymond Blank Memorial Hospital for Children
Des Moines, Iowa, United States, 50309
United States, Kansas
Wesley Medical Center
Wichita, Kansas, United States, 67214
United States, Kentucky
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, United States, 40536-0284
Kosair Children's Hospital
Louisville, Kentucky, United States, 40202-3830
United States, Louisiana
Children's Hospital of New Orleans
New Orleans, Louisiana, United States, 70118
Ochsner Clinic
New Orleans, Louisiana, United States, 70121
Tulane University School of Medicine
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
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, United States, 21201-1595
Sinai Hospital of Baltimore
Baltimore, Maryland, United States, 21225
United States, Massachusetts
Baystate Medical Center
Springfield, Massachusetts, United States, 01107
Floating Hospital for Children
Boston, Massachusetts, United States, 02111
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
University of Massachusetts Memorial Medical Center - University Campus
Worcester, Massachusetts, United States, 01655
United States, Michigan
Bronson Methodist Hospital
Kalamazoo, Michigan, United States, 49007
Children's Hospital of Michigan
Detroit, Michigan, United States, 48201
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Hurley Medical Center
Flint, Michigan, United States, 48503
Michigan State University
East Lansing, Michigan, United States, 48824
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073-6769
Spectrum Health and DeVos Children's Hospital
Grand Rapids, Michigan, United States, 49503
St. John Hospital and Medical Center
Detroit, Michigan, United States, 48236
Mott Children's Hospital
Ann Arbor, Michigan, United States, 48109-0914
United States, Minnesota
Children's Hospitals and Clinics - Minneapolis
Minneapolis, Minnesota, United States, 55404
Children's Hospitals and Clinics of Minnesota
Saint Paul, Minnesota, United States, 55102
St. Mary's/Duluth Clinic Cancer Center
Duluth, Minnesota, United States, 55805-1983
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216-4505
United States, Missouri
Cardinal Glennon Children's Hospital
Saint Louis, Missouri, United States, 63104
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
St. Louis Children's Hospital
Saint Louis, Missouri, United States, 63110
United States, Nebraska
Children's Hospital of Omaha
Omaha, Nebraska, United States, 68114
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-2168
United States, Nevada
Sunrise Hospital and Medical Center
Las Vegas, Nevada, United States, 89109-2306
United States, New Hampshire
Norris Cotton Cancer Center
Lebanon, New Hampshire, United States, 03756-0002
United States, New Jersey
Atlantic Health System
Summit, New Jersey, United States, 07901
Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Newark Beth Israel Medical Center
Newark, New Jersey, United States, 07112-2094
St. Joseph's Hospital and Medical Center
Paterson, New Jersey, United States, 07503
United States, New Mexico
University of New Mexico Cancer Research and Treatment Center
Albuquerque, New Mexico, United States, 87131
United States, New York
Cancer Center of Albany Medical Center
Albany, New York, United States, 12208
Brooklyn Hospital Center
Brooklyn, New York, United States, 11201
Brookdale University Hospital and Medical Center
Brooklyn, New York, United States, 11212
Columbia Presbyterian Hospital
New York, New York, United States, 10032
Maimonides Medical Center
Brooklyn, New York, United States, 11219
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Montefiore Medical Center
Bronx, New York, United States, 10467-2490
North Shore University Hospital
Manhasset, New York, United States, 11030
New York Medical College
Valhalla, New York, United States, 10595
New York Presbyterian Hospital - Cornell Campus
New York, New York, United States, 10021-4885
Mount Sinai School of Medicine
New York, New York, United States, 10029
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Schneider Children's Hospital
New Hyde Park, New York, United States, 11042
State University of New York - Upstate Medical University
Syracuse, New York, United States, 13210
State University of New York Health Science Center at Brooklyn College of Medicine
Brooklyn, New York, United States, 11203
State University of New York Health Sciences Center - Stony Brook
Stony Brook, New York, United States, 11790-7775
James P. Wilmot Cancer Center
Rochester, New York, United States, 14642
United States, North Carolina
Carolinas Medical Center
Charlotte, North Carolina, United States, 28232-2861
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States, 27157-1081
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
East Carolina University School of Medicine
Greenville, North Carolina, United States, 27858-4354
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States, 27599-7295
Mission Saint Joseph's Health System
Asheville, North Carolina, United States, 28801
Presbyterian Healthcare
Charlotte, North Carolina, United States, 28233-3549
United States, North Dakota
Dakota Cancer Institute
Fargo, North Dakota, United States, 58103-4940
United States, Ohio
Ireland Cancer Center
Cleveland, Ohio, United States, 44106-5065
Children's Hospital Medical Center of Akron
Akron, Ohio, United States, 44308
Children's Hospital of Columbus
Columbus, Ohio, United States, 43205-2696
Children's Medical Center - Dayton
Dayton, Ohio, United States, 45404
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
Forum Health-Tod Childrens Hospital
Youngstown, Ohio, United States, 44501
Children's Hospital Medical Center - Cincinnati
Cincinnati, Ohio, United States, 45229-2899
St. Vincent Mercy Medical Center
Toledo, Ohio, United States, 43608
Toledo Children's Hospital
Toledo, Ohio, United States, 43601
United States, Oklahoma
Children's Hospital of Oklahoma
Oklahoma City, Oklahoma, United States, 73104
Natalie Warren Bryant Cancer Center
Tulsa, Oklahoma, United States, 74136
United States, Oregon
Doernbecher Children's Hospital
Portland, Oregon, United States, 97201-3098
Legacy Emanuel Hospital and Health Center
Portland, Oregon, United States, 97227
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822-1320
Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, United States, 19134-1095
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02818
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425-0721
Children's Hospital of Greenville Hospital System
Greenville, South Carolina, United States, 29605
Palmetto Health South Carolina Cancer Center
Columbia, South Carolina, United States, 29203
United States, South Dakota
Avera Cancer Institute
Sioux Falls, South Dakota, United States, 57105-1080
Sioux Valley Hospital
Sioux Falls, South Dakota, United States, 57117
United States, Tennessee
East Tennessee Children's Hospital
Knoxville, Tennessee, United States, 37901
James H. Quillen College of Medicine
Johnson City, Tennessee, United States, 37614-0622
Saint Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105-2794
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Scott and White Memorial Hospital
Temple, Texas, United States, 76508
Cook Children's Medical Center - Fort Worth
Fort Worth, Texas, United States, 76104
Covenant Children's Hospital
Lubbock, Texas, United States, 79410
Medical City Dallas Hospital
Dallas, Texas, United States, 75230
Methodist Health Care System
San Antonio, Texas, United States, 78229-3902
San Antonio Military Pediatric Cancer and Blood Disorders Center
Lackland Air Force Base, Texas, United States, 78236-5300
Children's Hospital of Austin
Austin, Texas, United States, 78701
Simmons Cancer Center - Dallas
Dallas, Texas, United States, 75235-9154
Texas Tech University Health Sciences Center School of Medicine
Amarillo, Texas, United States, 79106
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78207
University of Texas Medical Branch
Galveston, Texas, United States, 77555-0361
United States, Utah
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
United States, Vermont
Vermont Cancer Center
Burlington, Vermont, United States, 05401-3498
United States, Virginia
Cancer Center at the University of Virginia
Charlottesville, Virginia, United States, 22908
Carilion Roanoke Community Hospital
Roanoke, Virginia, United States, 24013
Children's Hospital of the King's Daughters
Norfolk, Virginia, United States, 23507
Inova Fairfax Hospital
Falls Church, Virginia, United States, 22042-3300
Massey Cancer Center
Richmond, Virginia, United States, 23298-0037
Naval Medical Center, Portsmouth
Portsmouth, Virginia, United States, 23708-5100
United States, Washington
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, United States, 98105
Deaconess Medical Center
Spokane, Washington, United States, 99210-0248
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024
Group Health Cooperative of Puget Sound
Seattle, Washington, United States, 98112
Madigan Army Medical Center
Tacoma, Washington, United States, 98431-5000
Mary Bridge Children's Health Center
Tacoma, Washington, United States, 98415-0299
United States, West Virginia
West Virginia University Hospitals
Morgantown, West Virginia, United States, 26506-9300
West Virginia University - Charleston
Charleston, West Virginia, United States, 25302
Cabell-Huntington Hospital, Inc
Huntington, West Virginia, United States, 25701
United States, Wisconsin
CCOP - Green Bay
Green Bay, Wisconsin, United States, 54301
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States, 54601
Marshfield Clinic
Marshfield, Wisconsin, United States, 54449-5772
Midwest Children's Cancer Center
Milwaukee, Wisconsin, United States, 53226
St. Vincent Hospital
Green Bay, Wisconsin, United States, 54307-9070
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792-0001
Bellin Memorial Hospital
Green Bay, Wisconsin, United States, 54301
Australia, New South Wales
Children's Hospital at Westmead
Westmead, New South Wales, Australia, 2145
Sydney Children's Hospital
Randwick, New South Wales, Australia, 2031
Australia, Queensland
Royal Children's Hospital
Brisbane, Queensland, Australia, 4029
Australia, South Australia
Women's and Children's Hospital
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, 6001
Canada, Alberta
Alberta Children's Hospital
Calgary, Alberta, Canada, T2T 5C7
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
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 Children's Health and Rehabilitation Centre
St. John's, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Nova Scotia
IWK Health Centre
Halifax, Nova Scotia, Canada, B3J 3G9
Canada, Ontario
Children's Hospital of Western Ontario
London, Ontario, Canada, N6C 2V5
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada, K1H 8L1
Children's Hospital
Hamilton, Ontario, Canada, L8N 3Z5
Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Canada, Quebec
Centre Hospitalier de L'Universite Laval
Sainte Foy, Quebec, Canada, GIV 4G2
Hopital Sainte Justine
Montreal, Quebec, Canada, H3T 1C5
Laval University Medical Center
Sainte-Foy, Quebec, Canada, G1V 4G2
McGill University Health Center - Montreal Children's Hospital
Montreal, Quebec, Canada, H3H 1P3
Canada, Saskatchewan
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada, S4T 7T1
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada, S7N 4H4
Netherlands
Academisch Ziekenhuis Groningen
Groningen, Netherlands, 9700 RB
New Zealand
Starship Children's Hospital
Auckland, New Zealand
Puerto Rico
San Jorge Childrens Hospital
Santurce, Puerto Rico, 00912
University of Puerto Rico School of Medicine Medical Sciences Campus
San Juan, Puerto Rico, 00936-5067
Switzerland
Swiss Pediatric Oncology Group Lausanne
Lausanne, Switzerland, CH 1011
Swiss Pediatric Oncology Group Geneva
Geneva, Switzerland, CH 1211
Swiss Pediatric Oncology Group Bern
Bern, Switzerland, CH 3010
Sponsors and Collaborators
Children's Oncology Group
Investigators
Study Chair: Beverly J. Lange, MD Children's Hospital of Philadelphia
  More Information

Additional Information:
Publications:
Lange BJ, Smith FO, Feusner J, Barnard D, Dinndorf P, Feig S, Heerema NA, Arndt C, Arceci RJ, Seibel N, Weiman M, Dusenbery K, Shannon K, Luna-Fineman S, Gerbing RB, Alonzo TA. Outcomes in CCG-2961, a Children's Oncology Group phase 3 trial for untreated pediatric acute myeloid leukemia (AML): a report from the Children's Oncology Group. Blood. 2007 Nov 13; [Epub ahead of print]
Lange BJ, Gerbing RB, Feusner J, Skolnik J, Sacks N, Smith FO, Alonzo TA. Mortality in overweight and underweight children with acute myeloid leukemia. JAMA. 2005 Jan 12;293(2):203-11.
Lange BJ, Smith FO, Dinndorf PA, et al.: Outcomes in CCG-2961, a Children's Cancer Group Phase III trial for untreated acute myeloid leukemia (AML). [Abstract] Blood 106 (11): A-169, 2005.
Bhatla D, Gerbing RB, Alonzo TA, Conner H, Ross JA, Meshinchi S, Zhai X, Zamzow T, Mehta PA, Geiger H, Perentesis J, Davies SM. Cytidine deaminase genotype and toxicity of cytosine arabinoside therapy in children with acute myeloid leukemia. Br J Haematol. 2008 Nov 22; [Epub ahead of print]
Ho PA, Alonzo TA, Gerbing RB, Pollard J, Stirewalt DL, Hurwitz C, Heerema NA, Hirsch B, Raimondi SC, Lange B, Franklin JL, Radich JP, Meshinchi S. Prevalence and prognostic implications of CEBPA mutations in pediatric AML: a report from the Children's Oncology Group. Blood. 2009 Mar 20; [Epub ahead of print]
Bhatla D, Gerbing RB, Alonzo TA, Mehta PA, Deal K, Elliott J, Meshinchi S, Geiger H, Perentesis JP, Lange BJ, Davies SM. DNA repair polymorphisms and outcome of chemotherapy for acute myelogenous leukemia: a report from the Children's Oncology Group. Leukemia. 2007 Nov 22; [Epub ahead of print]
Horan JT, Alonzo TA, Lyman GH, Gerbing RB, Lange BJ, Ravindranath Y, Becton D, Smith FO, Woods WG. Impact of Disease Risk on Efficacy of Matched Related Bone Marrow Transplantation for Pediatric Acute Myeloid Leukemia: The Children's Oncology Group. J Clin Oncol. 2008 Oct 27; [Epub ahead of print]
Mehta PA, Gerbing RB, Alonzo TA, Elliott JS, Zamzow TA, Combs M, Stover E, Ross JA, Perentesis JP, Meschinchi S, Lange BJ, Davies SM. FAS promoter polymorphism: outcome of childhood acute myeloid leukemia. A children's oncology group report. Clin Cancer Res. 2008 Dec 1;14(23):7896-9.
Meshinchi S, Stirewalt DL, Alonzo TA, Boggon TJ, Gerbing RB, Rocnik JL, Lange BJ, Gilliland DG, Radich JP. Structural and numerical variation of FLT3/ITD in pediatric AML. Blood. 2008 Feb 27; [Epub ahead of print]
Sung L, Alonzo TA, Gerbing RB, Aplenc R, Lange BJ, Woods WG, Feusner J, Franklin J, Patterson MJ, Gamis AS. Respiratory syncytial virus infections in children with acute myeloid leukemia: A report from the Children's Oncology Group. Pediatr Blood Cancer. 2008 Aug 4; [Epub ahead of print]
Barbaric D, Alonzo TA, Gerbing RB, Meshinchi S, Heerema NA, Barnard DR, Lange BJ, Woods WG, Arceci RJ, Smith FO. Minimally differentiated acute myeloid leukemia (FAB AML-M0) is associated with an adverse outcome in children: a report from the Children's Oncology Group studies CCG-2891 and -2961. Blood. 2006 Dec 7; [Epub ahead of print]
Pollard J, Alonzo T, Gerbing R, et al.: Prevalence and prognostic significance of c-KIT mutations in pediatric CBF AML patients enrolled on serial CCG/COG protocols. [Abstract] Blood 110 (11): A-1442, 2007.
Brown P, McIntyre E, Rau R, et al.: Incidence and clinical significance of nucleophosmin mutations in childhood AML: a Childrens Oncology Group study. [Abstract] Blood 108 (11): A-221, 2006.
Children's Oncology Group; Aplenc R, Alonzo TA, Gerbing RB, Smith FO, Meshinchi S, Ross JA, Perentesis J, Woods WG, Lange BJ, Davies SM. Ethnicity and survival in childhood acute myeloid leukemia: a report from the Children's Oncology Group. Blood. 2006 Jul 1;108(1):74-80. Epub 2006 Mar 14.
Loh ML, Reynolds MG, Vattikuti S, Gerbing RB, Alonzo TA, Carlson E, Cheng JW, Lee CM, Lange BJ, Meshinchi S; Children's Cancer Group. PTPN11 mutations in pediatric patients with acute myeloid leukemia: results from the Children's Cancer Group. Leukemia. 2004 Nov;18(11):1831-4.
Perentesis JP, Alonzo TA, Gerbing R, et al.: Polymorphism in folate metabolism and outcomes of therapy in children with AML with and without Down Syndrome. [Abstract] Blood 102 (11 Pt 1): A-479, 2003.
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Study ID Numbers: CDR0000064883, COG-2961, CCG-2961
Study First Received: November 24, 2000
Last Updated: April 18, 2009
ClinicalTrials.gov Identifier: NCT00002798     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
untreated childhood acute myeloid leukemia and other myeloid malignancies
childhood acute myeloblastic leukemia without maturation (M1)
childhood acute myeloblastic leukemia with maturation (M2)
childhood acute myelomonocytic leukemia (M4)
childhood acute monoblastic leukemia (M5a)
childhood acute monocytic leukemia (M5b)
childhood acute erythroleukemia (M6)
childhood acute megakaryocytic leukemia (M7)
refractory anemia
refractory anemia with ringed sideroblasts
refractory anemia with excess blasts
refractory anemia with excess blasts in transformation
chronic myelomonocytic leukemia
de novo myelodysplastic syndromes
secondary myelodysplastic syndromes
childhood myelodysplastic syndromes

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Dexamethasone
Anti-Infective Agents
Hydrocortisone
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Hormones
Preleukemia
Pathologic Processes
Therapeutic Uses
Abortifacient Agents
Methotrexate
Dermatologic Agents
Etoposide
Nucleic Acid Synthesis Inhibitors
Asparaginase
Anti-HIV Agents
Antineoplastic Agents, Hormonal
Hematologic Diseases
Thioguanine
Leukemia, Myeloid
Abortifacient Agents, Nonsteroidal
Glucocorticoids
Idarubicin
Neoplasms
Aldesleukin
Fludarabine

ClinicalTrials.gov processed this record on November 22, 2009