Treatment of Newly Diagnosed Childhood Acute Myeloid Leukemia (AML) Using Intensive MRC-Based Therapy and Gemtuzumab Ozogamicin (GMTZ): A COG Pilot Study
Treatment of Newly Diagnosed Childhood Acute Myeloid Leukemia (AML) Using Intensive MRC-Based Therapy and Gemtuzumab Ozogamicin (GMTZ): A COG Pilot Study
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.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
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.
DISEASE CHARACTERISTICS:
Newly diagnosed primary acute myeloid leukemia (AML)
At least 20% bone marrow blasts
Meets the customary FAB criteria for AML
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
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Birmingham, Alabama 35294, United States
Little Rock, Arkansas 72205, United States
Loma Linda, California 92354-2870, United States
Long Beach, California 90801, United States
Los Angeles, California 90048-1865, United States
Hartford, Connecticut 06106, United States
Washington D.C., District of Columbia 20007-2197, United States
Savannah, Georgia 31404-6283, United States
Wichita, Kansas 67214, United States
Lexington, Kentucky 40506, United States
Baltimore, Maryland 21287-5001, United States
Ann Arbor, Michigan 48109-0238, United States
East Lansing, Michigan 48824-1313, United States
Grosse Point Woods, Michigan 48236, United States
Minneapolis, Minnesota 55455-0392, United States
Keesler Air Force Base, Mississippi 39534-2511, United States
New Brunswick, New Jersey 08901, United States
Albuquerque, New Mexico 87131-0001, United States
New York, New York 10032-1537, United States
The Bronx, New York 10467, United States
Chapel Hill, North Carolina 27599-7220, United States
Greenville, North Carolina 27834, United States
Winston-Salem, North Carolina 27157-1081, United States
Hershey, Pennsylvania 17033-0850, United States
Charleston, South Carolina 29425, United States
Sioux Falls, South Dakota 57117-5039, United States
Dallas, Texas 75390-9063, United States
Burlington, Vermont 05405, United States
Richmond, Virginia 23298-0121, United States
Spokane, Washington 99220-2555, United States
Charleston, West Virginia 25302, United States
La Crosse, Wisconsin 54601-5429, United States
Herston, Brisbane, Queensland 4029, Australia
St. John's, Newfoundland and Labrador A1B 3V6, Canada
Ste-Foy, Quebec G1V 4G2, Canada