Gemtuzumab Ozogamicin in Treating Young Patients With Newly Diagnosed Acute Myeloid Leukemia Undergoing Remission Induction and Intensification Therapy
Leukemia
About this trial
This is an interventional treatment trial for Leukemia focused on measuring 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)
Eligibility 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
Sites / Locations
- Comprehensive Cancer Center at University of Alabama at Birmingham
- Phoenix Children's Hospital
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
- Southern California Permanente Medical Group
- Loma Linda University Cancer Institute at Loma Linda University Medical Center
- Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
- Children's Hospital Los Angeles
- Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
- Children's Hospital Central California
- Children's Hospital and Research Center - Oakland
- Children's Hospital of Orange County
- University of California Davis Cancer Center
- Sutter Cancer Center
- Kaiser Permanente Medical Center - Oakland
- Children's Hospital and Health Center - San Diego
- Children's Hospital Cancer Center
- Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
- Alfred I. duPont Hospital for Children
- Lombardi Cancer Center at Georgetown University Medical Center
- Children's National Medical Center
- Broward General Medical Center Cancer Center
- Lee Cancer Care of Lee Memorial Health System
- University of Florida Shands Cancer Center
- Memorial Cancer Institute at Memorial Regional Hospital
- Nemours Children's Clinic
- University of Miami Sylvester Comprehensive Cancer Center
- Miami Children's Hospital
- Baptist-South Miami Regional Cancer Program
- Florida Hospital Cancer Institute at Florida Hospital Orlando
- M.D. Anderson Cancer Center - Orlando
- Sacred Heart Cancer Center at Sacred Heart Hospital
- All Children's Hospital
- St. Joseph's Cancer Institute at St. Joseph's Hospital
- Kaplan Cancer Center at St. Mary's Medical Center
- Emory University Hospital - Atlanta
- Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
- Cancer Research Center of Hawaii
- St. Luke's Mountain States Tumor Institute - Boise
- Children's Memorial Hospital - Chicago
- University of Chicago Cancer Research Center
- Lutheran General Cancer Care Center
- Southern Illinois University School of Medicine
- Indiana University Cancer Center
- St. Vincent Indianapolis Hospital
- Holden Comprehensive Cancer Center at University of Iowa
- Via Christi Cancer Center at Via Christi Regional Medical Center
- Wesley Medical Center
- Markey Cancer Center at University of Kentucky Chandler Medical Center
- Kosair Children's Hospital
- CancerCare of Maine at Eastern Maine Medial Center
- Maine Children's Cancer Program
- Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Floating Hospital for Children
- C.S. Mott Children's Hospital at University of Michigan
- Barbara Ann Karmanos Cancer Institute
- Breslin Cancer Center at Ingham Regional Medical Center
- Spectrum Health Cancer Care - Butterworth Campus
- Van Elslander Cancer Center at St. John Hospital and Medical Center
- CCOP - Kalamazoo
- Children's Hospitals and Clinics - Minneapolis/St. Paul
- Fairview University Medical Center - University Campus
- Mayo Clinic Cancer Center
- University of Mississippi Medical Center
- Keesler Medical Center - Keesler Air Force Base
- Children's Mercy Hospital
- Cardinal Glennon Children's Hospital
- Siteman Cancer Center at Barnes-Jewish Hospital
- Children's Hospital of Omaha
- Sunrise Hospital and Medical Center
- Hackensack University Medical Center
- St. Barnabas Medical Center
- Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
- Newark Beth Israel Medical Center
- St. Joseph's Hospital and Medical Center
- University of New Mexico Cancer Research and Treatment Center
- Albert Einstein Cancer Center at Albert Einstein College of Medicine
- Brooklyn Hospital Center
- Maimonides Medical Center
- Roswell Park Cancer Institute
- Winthrop University Hospital
- Schneider Children's Hospital
- Herbert Irving Comprehensive Cancer Center at Columbia University
- SUNY Upstate Medical University Hospital
- New York Medical College
- Mission Hospitals - Memorial Campus
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
- Blumenthal Cancer Center at Carolinas Medical Center
- Presbyterian Cancer Center at Presbyterian Hospital
- Leo W. Jenkins Cancer Center at Pitt County Memorial Hospital
- Comprehensive Cancer Center at Wake Forest University
- CCOP - MeritCare Hospital
- Children's Hospital Medical Center of Akron
- Cincinnati Children's Hospital Medical Center
- Rainbow Babies and Children's Hospital
- Cleveland Clinic Taussig Cancer Center
- Columbus Children's Hospital
- Children's Medical Center - Dayton
- Toledo Hospital
- Medical College of Ohio Cancer Institute
- Oklahoma University Medical Center
- Cancer Institute at Oregon Health and Science University
- Geisinger Medical Center
- Penn State Cancer Institute at Milton S. Hershey Medical Center
- Children's Hospital of Philadelphia
- St. Christopher's Hospital for Children
- Children's Hospital of Pittsburgh
- Hollings Cancer Center at Medical University of South Carolina
- Palmetto Health South Carolina Cancer Center
- Sioux Valley Hospital and University of South Dakota Medical Center
- Vanderbilt-Ingram Cancer Center
- Texas Tech University Health Sciences Center School of Medicine
- Children's Hospital of Austin
- Driscoll Children's Hospital
- Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
- Covenant Children's Hospital
- University of Texas Health Science Center at San Antonio
- Methodist Children's Hospital of South Texas
- CCOP - Scott and White Hospital
- Primary Children's Medical Center
- Fletcher Allen Health Care - University Health Center Campus
- INOVA Fairfax Hospital
- Massey Cancer Center at Virginia Commonwealth University
- Carilion Cancer Center of Western Virginia
- Children's Hospital and Regional Medical Center - Seattle
- Providence Cancer Center at Sacred Heart Medical Center
- Mary Bridge Children's Hospital and Health Center - Tacoma
- Madigan Army Medical Center
- West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division
- Cabell Huntington Hospital
- St. Vincent Hospital
- Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
- University of Wisconsin Comprehensive Cancer Center
- Midwest Children's Cancer Center
- Westmead Hospital
- Office of S. David Lang
- Princess Margaret Hospital for Children
- Alberta Children's Hospital
- Children's & Women's Hospital of British Columbia
- CancerCare Manitoba
- Janeway Children's Health and Rehabilitation Centre
- IWK Health Centre
- McMaster Children's Hospital at Hamilton Health Sciences
- McGill Cancer Centre at McGill University
- Hopital Sainte Justine
- Centre Hospitalier Universitaire de Quebec
- San Jorge Children's Hospital
- Swiss Pediatric Oncology Group Bern