Acute Myeloid Leukemia Clinical Trial
Detection of Residual Disease in Children Receiving Therapy for Acute Myeloid Leukemia or Myelodysplastic Syndrome
Summary
RATIONALE: Diagnostic procedures may improve the ability to detect residual disease.
PURPOSE: Clinical trial to detect the presence of residual disease in children who are receiving therapy for acute myeloid leukemia or myelodysplastic syndrome.
Full Description
OBJECTIVES: I. Determine the frequency and prognostic significance of persistent abnormal cells with an aberrant phenotype detected by multidimensional flow cytometry (MDF) in bone marrow samples from children who have achieved clinical remission after receiving treatment for acute myeloid leukemia or myelodysplastic syndrome. II. Compare the frequency of persistent abnormal cells obtained by MDF with that of polymerase chain reaction (PCR), morphologic, and cytogenetic analyses of these patient samples. III. Determine the frequency and prognostic significance of persistent abnormal cells with a leukemia-specific molecular marker detected by PCR in samples from these patients.
OUTLINE: Patients have bone marrow samples collected during the course of therapy on the CCG 2961 acute myeloid leukemia treatment protocol. These samples are collected: 1. At the time of diagnosis 2. At the end of induction (within a week of day 35) 3. At the end of consolidation (before bone marrow transplant or Capizzi 2) 4. Before and after interleukin-2 (IL-2) therapy, if applicable 5. At the end of therapy (after transplant with evidence of engraftment for autologous bone marrow transplant patients; after course 2 of intensification for chemotherapy patients; and after IL-2 day 21 for IL-2 patients) 6. At relapse, if applicable. The presence of minimal residual disease in bone marrow is assessed using multidimensional flow cytometry and PCR.
PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study.
Eligibility Criteria
DISEASE CHARACTERISTICS: Acute myeloid leukemia (AML) or myelodysplastic syndrome and enrolled on the CCG 2961 AML treatment protocol Must have one of the following cytogenetic abnormalities t(8;21) inv(16) abnormality of 11q23 OR All patients being enrolled for interleukin-2 therapy or standard care can be enrolled at the time of randomization
PATIENT CHARACTERISTICS: Age: Children Performance status: Specified on the CCG 2961 AML treatment protocol Life expectancy: Specified on the CCG 2961 AML treatment protocol Hematopoietic: Specified on the CCG 2961 AML treatment protocol Hepatic: Specified on the CCG 2961 AML treatment protocol Renal: Specified on the CCG 2961 AML treatment protocol
PRIOR CONCURRENT THERAPY: Specified on the CCG 2961 AML treatment protocols
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There are 42 Locations for this study
Long Beach California, 90806, United States
Los Angeles California, 90027, United States
Los Angeles California, 90033, United States
Los Angeles California, 90095, United States
Orange California, 92868, United States
San Francisco California, 94115, United States
Travis Air Force Base California, 94535, United States
Denver Colorado, 80218, United States
Washington District of Columbia, 20010, United States
Chicago Illinois, 60637, United States
Indianapolis Indiana, 46202, United States
Iowa City Iowa, 52242, United States
Ann Arbor Michigan, 48109, United States
Kalamazoo Michigan, 49007, United States
Minneapolis Minnesota, 55455, United States
Rochester Minnesota, 55905, United States
Roseville Minnesota, 55113, United States
Kansas City Missouri, 64108, United States
Omaha Nebraska, 68198, United States
New Brunswick New Jersey, 08901, United States
New Brunswick New Jersey, 08901, United States
New York New York, 10016, United States
New York New York, 10021, United States
New York New York, 10032, United States
Chapel Hill North Carolina, 27599, United States
Fargo North Dakota, 58102, United States
Fargo North Dakota, 58122, United States
Cincinnati Ohio, 45229, United States
Cleveland Ohio, 44106, United States
Columbus Ohio, 43205, United States
Portland Oregon, 97201, United States
Philadelphia Pennsylvania, 19104, United States
Pittsburgh Pennsylvania, 15213, United States
Columbia South Carolina, 29203, United States
Nashville Tennessee, 37232, United States
Houston Texas, 77030, United States
Salt Lake City Utah, 84132, United States
Seattle Washington, 98105, United States
Seattle Washington, 98109, United States
Madison Wisconsin, 53792, United States
Perth Western Australia, 6001, Australia
Vancouver British Columbia, V6H 3, Canada
Halifax Nova Scotia, B3J 3, Canada
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