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Gemtuzumab Ozogamicin in Treating Young Patients With Newly Diagnosed Acute Myeloid Leukemia Undergoing Remission Induction and Intensification Therapy
This study has been completed.
First Received: October 3, 2003   Last Updated: March 26, 2009   History of Changes
Sponsor: Children's Oncology Group
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00070174
  Purpose

RATIONALE: Giving chemotherapy before a donor bone marrow transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. Also, monoclonal antibodies, such as gemtuzumab ozogamicin, can find cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.

PURPOSE: This phase II trial is studying how well gemtuzumab ozogamicin works in treating young patients who are undergoing remission induction, intensification therapy, and allogeneic bone marrow transplant for newly diagnosed acute myeloid leukemia.


Condition Intervention Phase
Leukemia
 Drug: asparaginase
Drug: busulfan
Drug: cyclophosphamide
Drug: cyclosporine
Drug: cytarabine
Drug: daunorubicin hydrochloride
Drug: etoposide
Drug: gemtuzumab ozogamicin
Drug: methotrexate
Drug: mitoxantrone hydrochloride
Procedure: allogeneic bone marrow transplantation
 Phase II

Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Treatment of Newly Diagnosed Childhood Acute Myeloid Leukemia (AML) Using Intensive MRC-Based Therapy and Gemtuzumab Ozogamicin (GMTZ): A COG Pilot Study

Resource links provided by NLM:

MedlinePlus related topics: Bone Marrow Transplantation Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood
Drug Information available for: Cyclophosphamide Busulfan Methotrexate Cytarabine hydrochloride Daunorubicin Daunorubicin hydrochloride Etoposide Cyclosporine Mitoxantrone Mitoxantrone hydrochloride Cyclosporin Etoposide phosphate Gemtuzumab ozogamicin Cytarabine L-Asparaginase
U.S. FDA Resources

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

Primary Outcome Measures:
  • Safety [ Designated as safety issue: Yes ]
  • Complete remission rate [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Feasibility [ Designated as safety issue: No ]
  • Effect of karyotypic abnormalities [ Designated as safety issue: No ]

Study Start Date: December 2003
Detailed Description:

OBJECTIVES:

Primary

  • Determine the safety of gemtuzumab ozogamicin in children with newly diagnosed acute myeloid leukemia undergoing intensive remission induction and intensification therapy.
  • Determine the complete remission rate of patients treated with this regimen.

Secondary

  • Determine the feasibility of performing biological studies (e.g., FLT3-ITD and MRD) for risk group stratification in these patients.
  • Determine the effect of karyotypic abnormalities on survival in patients treated with this regimen.

OUTLINE: This is a multicenter study.

  • Induction I: Patients receive high-dose cytarabine (ARA-C) IV twice daily on days 1-10; daunorubicin IV over 6 hours on days 1, 3, and 5; etoposide IV over 4 hours on days 1-5; and gemtuzumab ozogamicin IV over 2 hours on day 6. Patients with CNS-negative disease receive ARA-C intrathecally (IT) on day 1. Patients with CNS-positive disease receive ARA-C IT twice weekly for 2-3 weeks. Between days 28-35, patients are evaluated. Patients achieving remission or who have no more than 20% blasts proceed to induction II.
  • Induction II: Patients receive ARA-C IV twice daily on days 1-8; ARA-C IT on day 1; and daunorubicin IV and etoposide IV as in induction I. Between days 28-35 patients are evaluated. Patients achieving complete remission proceed to intensification course I.
  • Intensification course I: Patients receive ARA-C IV over 1 hour twice daily on days 1-5; ARA-C IT as in induction II; and etoposide IV over 1 hour on days 1-5. Patients are evaluated at day 28. Patients with a 5/6 or 6/6 matched family donor proceed to allogeneic bone marrow transplantation. All other patients in complete remission proceed to intensification course II.
  • Intensification course II: Patients receive ARA-C IV over 2 hours twice daily on days 1-4; ARA-C IT as in induction II; mitoxantrone IV over 1 hour on days 3-6; and gemtuzumab ozogamicin IV over 2 hours on day 7. Patients are evaluated on day 28 and then proceed to intensification course III.
  • Intensification course III: Patients receive ARA-C IV over 3 hours twice daily on days 1, 2, 8, and 9 and asparaginase intramuscularly on days 2 and 9.
  • Allogeneic bone marrow transplantation: Patients receive a preparative regimen comprising busulfan IV over 2 hours 4 times daily on days -9 to -6 and cyclophosphamide IV over 1 hour once daily on days -5 to -2. Allogeneic stem cells are infused on day 0.
  • Graft-versus-host disease prophylaxis: Patients receive oral or IV cyclosporine twice daily on days -1 to 50 and methotrexate IV once daily on days 1, 3, 6, and 11.

In all courses, treatment continues in the absence of disease progression or unacceptable toxicity.

Patients are followed monthly for 6 months, every 2 months for 6 months, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 330 patients will be accrued for this study.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Newly diagnosed primary acute myeloid leukemia (AML)

    • At least 20% bone marrow blasts

    • Meets the customary FAB criteria for AML

      • Patients with cytopenias and bone marrow blasts who do not meet the FAB criteria are eligible provided they have a karyotypic abnormality characteristic of de novo AML (e.g., t[8;21], inv16, or t[16;16]) OR they have the unequivocal presence of megakaryoblasts
    • Isolated granulocytic sarcoma (myeloblastoma) allowed regardless of the results outlined above
  • Previously untreated disease
  • No promyelocytic leukemia (FAB M3)
  • No documented myelodysplastic syndromes (preleukemia) (e.g., chronic myelomonocytic leukemia, refractory anemia [RA], RA with excess blasts, or RA with ringed sideroblasts)
  • No juvenile myelomonocytic leukemia
  • No Fanconi's anemia, Kostmann syndrome, Shwachman syndrome, or any other known bone marrow failure syndrome
  • No Down syndrome

PATIENT CHARACTERISTICS:

Age

  • 1 month to 21 years* NOTE: *Children under 1 month of age who have progressive disease are allowed

Performance status

  • Karnofsky 50-100% (over 16 years of age) OR
  • Lansky 50-100% (ages 1 to 16)* NOTE: Children under 1 year of age do not require a performance status

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • No inadequate liver function

Renal

  • No inadequate renal function
  • No hyperuricemia (greater than 8.0 mg/dL)
  • Creatinine clearance or radioisotope glomerular filtration rate (GFR) at least 70 mL/min OR an equivalent normal GFR OR
  • Creatinine no greater than 1.5 times normal

Cardiovascular

  • Shortening fraction at least 27% by echocardiogram OR
  • Ejection fraction at least 50% by MUGA

Pulmonary

  • No proven or suspected pneumonia

Other

  • Not pregnant or nursing
  • No proven or suspected sepsis or meningitis

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior chemotherapy except intrathecal cytarabine administered that was administered at diagnosis

Endocrine therapy

  • Prior topical and inhalation steroids allowed
  • No concurrent steroids as antiemetics

Radiotherapy

  • No prior radiotherapy

Surgery

  • Not specified

Other

  • No prior antileukemic therapy
  • No concurrent pressor agent or ventilatory support unless approved by the study chair
  • No concurrent participation in another COG therapeutic study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00070174

  Hide Study Locations
Locations
United States, Alabama
Comprehensive Cancer Center at University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Arizona
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016-7710
United States, Arkansas
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
Children's Hospital and Health Center - San Diego
San Diego, California, United States, 92123-4282
Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
Long Beach, California, United States, 90801
Children's Hospital Central California
Madera, California, United States, 93638-8762
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
Children's Hospital of Orange County
Orange, California, United States, 92668
Children's Hospital and Research Center - Oakland
Oakland, California, United States, 94609-1809
Kaiser Permanente Medical Center - Oakland
Sacramento, California, United States, 95825
Loma Linda University Cancer Institute at Loma Linda University Medical Center
Loma Linda, California, United States, 92354-2870
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048-1865
Southern California Permanente Medical Group
Downey, California, United States, 90242-2814
Sutter Cancer Center
Sacramento, California, United States, 95819
University of California Davis Cancer Center
Sacramento, California, United States, 95817
United States, Colorado
Children's Hospital Cancer Center
Denver, Colorado, United States, 80218-1088
United States, Connecticut
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
Hartford, Connecticut, United States, 06106
United States, Delaware
Alfred I. duPont Hospital for Children
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 at Georgetown University Medical Center
Washington, District of Columbia, United States, 20007-2197
United States, Florida
All Children's Hospital
St. Petersburg, Florida, United States, 33701
Baptist-South Miami Regional Cancer Program
Miami, Florida, United States, 33176
Broward General Medical Center Cancer Center
Ft. Lauderdale, Florida, United States, 33316
Memorial Cancer Institute at Memorial Regional Hospital
Hollywood, Florida, United States, 33021
Kaplan Cancer Center at St. Mary's Medical Center
West Palm Beach, Florida, United States, 33407
Lee Cancer Care of Lee Memorial Health System
Ft. Myers, Florida, United States, 33908
M.D. Anderson Cancer Center - Orlando
Orlando, Florida, United States, 32806
Florida Hospital Cancer Institute at Florida Hospital Orlando
Orlando, Florida, United States, 32804
Miami Children's Hospital
Miami, Florida, United States, 33155
Nemours Children's Clinic
Jacksonville, Florida, United States, 32207
Sacred Heart Cancer Center at Sacred Heart Hospital
Pensacola, Florida, United States, 32504
St. Joseph's Cancer Institute at St. Joseph's Hospital
Tampa, Florida, United States, 33607
University of Florida Shands Cancer Center
Gainesville, Florida, United States, 32610
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33101
United States, Georgia
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
Savannah, Georgia, United States, 31404-6283
Emory University Hospital - Atlanta
Atlanta, Georgia, United States, 30322
United States, Hawaii
Cancer Research Center of Hawaii
Honolulu, Hawaii, United States, 95813
United States, Idaho
St. Luke's Mountain States Tumor Institute - Boise
Boise, Idaho, United States, 83712-6297
United States, Illinois
Children's Memorial Hospital - Chicago
Chicago, Illinois, United States, 60614
Lutheran General Cancer Care Center
Park Ridge, Illinois, United States, 60068-1174
Southern Illinois University School of Medicine
Springfield, Illinois, United States, 62794-9230
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1463
United States, Indiana
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202-5225
St. Vincent Indianapolis Hospital
Indianapolis, Indiana, United States, 46260
United States, Iowa
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States, 52242-1083
United States, Kansas
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, United States, 67214
Wesley Medical Center
Wichita, Kansas, United States, 67214
United States, Kentucky
Kosair Children's Hospital
Louisville, Kentucky, United States, 40202-1822
Markey Cancer Center at University of Kentucky Chandler Medical Center
Lexington, Kentucky, United States, 40506
United States, Maine
CancerCare of Maine at Eastern Maine Medial Center
Bangor, Maine, United States, 04401
Maine Children's Cancer Program
Scarborough, Maine, United States, 04074-9308
United States, Maryland
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
Baltimore, Maryland, United States, 21215
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21287-5001
United States, Massachusetts
Floating Hospital for Children
Boston, Massachusetts, United States, 02111
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Breslin Cancer Center at Ingham Regional Medical Center
East Lansing, Michigan, United States, 48824-1313
C.S. Mott Children's Hospital at University of Michigan
Ann Arbor, Michigan, United States, 48109-0238
CCOP - Kalamazoo
Kalamazoo, Michigan, United States, 49007-5341
Spectrum Health Cancer Care - Butterworth Campus
Grand Rapids, Michigan, United States, 49503-2560
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Point Woods, Michigan, United States, 48236
United States, Minnesota
Children's Hospitals and Clinics - Minneapolis/St. Paul
Minneapolis, Minnesota, United States, 55404
Fairview University Medical Center - University Campus
Minneapolis, Minnesota, United States, 55455-0392
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905-0001
United States, Mississippi
Keesler Medical Center - Keesler Air Force Base
Keesler AFB, Mississippi, United States, 39534-2511
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216-4505
United States, Missouri
Cardinal Glennon Children's Hospital
St. Louis, Missouri, United States, 63104
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
Siteman Cancer Center at Barnes-Jewish Hospital
St. Louis, Missouri, United States, 63110
United States, Nebraska
Children's Hospital of Omaha
Omaha, Nebraska, United States, 68114-4113
United States, Nevada
Sunrise Hospital and Medical Center
Las Vegas, Nevada, United States, 89109-2306
United States, New Jersey
St. Barnabas Medical Center
Livingston, New Jersey, United States, 07039
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Newark Beth Israel Medical Center
Newark, New Jersey, United States, 07112-2094
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08901
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, 87131-0001
United States, New York
Albert Einstein Cancer Center at Albert Einstein College of Medicine
Bronx, New York, United States, 10467
Brooklyn Hospital Center
Brooklyn, New York, United States, 11201-5493
Herbert Irving Comprehensive Cancer Center at Columbia University
New York, New York, United States, 10032-1537
SUNY Upstate Medical University Hospital
Syracuse, New York, United States, 13210
New York Medical College
Valhalla, New York, United States, 10595
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Schneider Children's Hospital
New Hyde Park, New York, United States, 11040
Maimonides Medical Center
Brooklyn, New York, United States, 11219
Winthrop University Hospital
Mineola, New York, United States, 11501
United States, North Carolina
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, United States, 28232
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States, 27157-1081
Leo W. Jenkins Cancer Center at Pitt County Memorial Hospital
Greenville, North Carolina, United States, 27834
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7220
Mission Hospitals - Memorial Campus
Asheville, North Carolina, United States, 28801-4690
Presbyterian Cancer Center at Presbyterian Hospital
Charlotte, North Carolina, United States, 28233
United States, North Dakota
CCOP - MeritCare Hospital
Fargo, North Dakota, United States, 58122
United States, Ohio
Children's Hospital Medical Center of Akron
Akron, Ohio, United States, 44308-1062
Children's Medical Center - Dayton
Dayton, Ohio, United States, 45404-1815
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229-3039
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195-5217
Columbus Children's Hospital
Columbus, Ohio, United States, 43205-2696
Medical College of Ohio Cancer Institute
Toledo, Ohio, United States, 43608
Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States, 44106-5000
Toledo Hospital
Toledo, Ohio, United States, 43606
United States, Oklahoma
Oklahoma University Medical Center
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Cancer Institute at Oregon Health and Science University
Portland, Oregon, United States, 97201-3098
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104-9786
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213-2583
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822-1320
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, United States, 19134
United States, South Carolina
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Palmetto Health South Carolina Cancer Center
Columbia, South Carolina, United States, 29203-6897
United States, South Dakota
Sioux Valley Hospital and University of South Dakota Medical Center
Sioux Falls, South Dakota, United States, 57117-5039
United States, Tennessee
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6310
United States, Texas
CCOP - Scott and White Hospital
Temple, Texas, United States, 76508
Children's Hospital of Austin
Austin, Texas, United States, 78701
Covenant Children's Hospital
Lubbock, Texas, United States, 79410
Driscoll Children's Hospital
Corpus Christi, Texas, United States, 78411-1721
Methodist Children's Hospital of South Texas
San Antonio, Texas, United States, 78229-3993
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States, 75390-9063
Texas Tech University Health Sciences Center School of Medicine
Amarillo, Texas, United States, 79106
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78207
United States, Utah
Primary Children's Medical Center
Salt Lake City, Utah, United States, 84113-1100
United States, Vermont
Fletcher Allen Health Care - University Health Center Campus
Burlington, Vermont, United States, 05405
United States, Virginia
Carilion Cancer Center of Western Virginia
Roanoke, Virginia, United States, 24029
INOVA Fairfax Hospital
Fairfax, Virginia, United States, 22031
Massey Cancer Center at Virginia Commonwealth University
Richmond, Virginia, United States, 23298-0121
United States, Washington
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, United States, 98105
Madigan Army Medical Center
Tacoma, Washington, United States, 98431
Mary Bridge Children's Hospital and Health Center - Tacoma
Tacoma, Washington, United States, 98405
Providence Cancer Center at Sacred Heart Medical Center
Spokane, Washington, United States, 99220-2555
United States, West Virginia
Cabell Huntington Hospital
Huntington, West Virginia, United States, 25701
West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division
Charleston, West Virginia, United States, 25302
United States, Wisconsin
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States, 54601-5429
Midwest Children's Cancer Center
Milwaukee, Wisconsin, United States, 53226
St. Vincent Hospital
Green Bay, Wisconsin, United States, 54301
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-0001
Australia, New South Wales
Westmead Hospital
Westmead, New South Wales, Australia, 2145
Australia, Queensland
Office of S. David Lang
Herston, Brisbane, Queensland, Australia, 4029
Australia, Western Australia
Princess Margaret Hospital for Children
Perth, Western Australia, Australia, 6001
Canada, Alberta
Alberta Children's Hospital
Calgary, Alberta, Canada, T2T 5C7
Canada, British Columbia
Children's & Women's Hospital of British Columbia
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, B3K 6R8
Canada, Ontario
McMaster Children's Hospital at Hamilton Health Sciences
Hamilton, Ontario, Canada, L8N 3Z5
Canada, Quebec
Centre Hospitalier Universitaire de Quebec
Ste-Foy, Quebec, Canada, G1V 4G2
Hopital Sainte Justine
Montreal, Quebec, Canada, H3T 1C5
McGill Cancer Centre at McGill University
Montreal, Quebec, Canada, H3H 1P3
Puerto Rico
San Jorge Children's Hospital
Santurce, Puerto Rico, 00912
Switzerland, Chihuahua
Swiss Pediatric Oncology Group Bern
Bern, Chihuahua, Switzerland, 3010
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Study Chair: Janet Franklin, MD, MPH Children's Hospital Los Angeles
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications:
Franklin J, Alonzo T, Hurwitz CA, et al.: COG AAML03P1: efficacy and safety in a pilot study of intensive chemotherapy including gemtuzumab in children newly diagnosed with acute myeloid leukemia (AML). [Abstract] Blood 112 (11): A- 136, 2008.
Pollard JA, Alonzo T, Gerbing R, et al.: Correlation of CD 33 expression level with disease characteristics and response to gemtuzumab ozogamycin-containing chemotherapy in childhood AML. [Abstract] Blood 112 (11): A-148, 2008.
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]
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]
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.

Study ID Numbers: CDR0000330133, COG-AAML03P1
Study First Received: October 3, 2003
Last Updated: March 26, 2009
ClinicalTrials.gov Identifier: NCT00070174     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 monocytic leukemia (M5b)
childhood acute megakaryocytic leukemia (M7)
childhood acute minimally differentiated myeloid leukemia (M0)
childhood acute myeloblastic leukemia with maturation (M2)
 childhood acute myeloblastic leukemia without maturation (M1)
childhood acute myelomonocytic leukemia (M4)
childhood acute monoblastic leukemia (M5a)
childhood acute erythroleukemia (M6)

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Daunorubicin
Antimetabolites, Antineoplastic
Cyclosporine
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Reproductive Control Agents
Cyclophosphamide
Antibiotics, Antineoplastic
Leukemia, Myeloid, Acute
Cyclosporins
Antibodies, Monoclonal
 Leukemia
Sensory System Agents
Antifungal Agents
Therapeutic Uses
Abortifacient Agents
Methotrexate
Analgesics
Dermatologic Agents
Etoposide
Alkylating Agents
Nucleic Acid Synthesis Inhibitors
Cytarabine
Asparaginase
Neoplasms by Histologic Type
Enzyme Inhibitors

ClinicalTrials.gov processed this record on November 30, 2009



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