Detection of Residual Disease in Children Receiving Therapy for Acute Myeloid Leukemia or Myelodysplastic Syndrome
- Conditions
- LeukemiaMyelodysplastic Syndromes
- Registration Number
- NCT00003790
- Lead Sponsor
- Children's Oncology Group
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 496
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Determine the frequency and prognostic significance of persistent abnormal cells with an aberrant phenotype detected by MDF in bone marrow samples from patients who have achieved clinical remission. 12 months from achievement of remission
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (43)
Children's Hospital of Orange County
🇺🇸Orange, California, United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center
🇺🇸New York, New York, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
Children's Mercy Hospital
🇺🇸Kansas City, Missouri, United States
Lineberger Comprehensive Cancer Center, UNC
🇺🇸Chapel Hill, North Carolina, United States
Children's Hospital Los Angeles
🇺🇸Los Angeles, California, United States
USC/Norris Comprehensive Cancer Center
🇺🇸Los Angeles, California, United States
Long Beach Memorial Medical Center
🇺🇸Long Beach, California, United States
Jonsson Comprehensive Cancer Center, UCLA
🇺🇸Los Angeles, California, United States
David Grant Medical Center
🇺🇸Travis Air Force Base, California, United States
Princess Margaret Hospital for Children
🇦🇺Perth, Western Australia, Australia
Center for Cancer Treatment and Research
🇺🇸Columbia, South Carolina, United States
UCSF Cancer Center and Cancer Research Institute
🇺🇸San Francisco, California, United States
Children's Hospital of Denver
🇺🇸Denver, Colorado, United States
Indiana University Cancer Center
🇺🇸Indianapolis, Indiana, United States
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
University of Minnesota Cancer Center
🇺🇸Minneapolis, Minnesota, United States
Ireland Cancer Center
🇺🇸Cleveland, Ohio, United States
Children's Hospital of Columbus
🇺🇸Columbus, Ohio, United States
University of Texas - MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Huntsman Cancer Institute
🇺🇸Salt Lake City, Utah, United States
Children's Hospital of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Vanderbilt Cancer Center
🇺🇸Nashville, Tennessee, United States
Children's Hospital and Regional Medical Center - Seattle
🇺🇸Seattle, Washington, United States
Fred Hutchinson Cancer Research Center
🇺🇸Seattle, Washington, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States
CCOP - Kalamazoo
🇺🇸Kalamazoo, Michigan, United States
Wayne Hughes Institute
🇺🇸Roseville, Minnesota, United States
Saint Peter's University Hospital
🇺🇸New Brunswick, New Jersey, United States
Herbert Irving Comprehensive Cancer Center
🇺🇸New York, New York, United States
CCOP - Merit Care Hospital
🇺🇸Fargo, North Dakota, United States
Veterans Affairs Medical Center - Fargo
🇺🇸Fargo, North Dakota, United States
Children's Hospital Medical Center - Cincinnati
🇺🇸Cincinnati, Ohio, United States
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
IWK Grace Health Centre
🇨🇦Halifax, Nova Scotia, Canada
University of Wisconsin Comprehensive Cancer Center
🇺🇸Madison, Wisconsin, United States
University of Michigan Comprehensive Cancer Center
🇺🇸Ann Arbor, Michigan, United States
Doernbecher Children's Hospital
🇺🇸Portland, Oregon, United States
Cancer Institute of New Jersey
🇺🇸New Brunswick, New Jersey, United States
Children's National Medical Center
🇺🇸Washington, District of Columbia, United States
British Columbia Children's Hospital
🇨🇦Vancouver, British Columbia, Canada