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Home > "D" Clinical Trials Conditions > Detection of Residual Disease in Children Receiving Therapy for Acute Myeloid Leukemia or Myelodysplastic Syndrome Detection of Residual Disease in Children Receiving Therapy for Acute Myeloid Leukemia or Myelodysplastic Syndrome
Detection of Residual Disease in Children Receiving Therapy for Acute Myeloid Leukemia or Myelodysplastic Syndrome
For Condition: de novo myelodysplastic syndrome,secondary myelodysplastic syndrome,Previously Treated Myelodysplastic Syndrome,untreated childhood acute myeloid leukemia,recurrent childhood acute myeloid leukemia
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Children's Cancer Group
Synopsis: 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.
Details: 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. PROTOCOL 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:
Study Type: Interventional, Diagnostic
Minimum Age/Maximum Age: /21 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY 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 --Prior/Concurrent Therapy-- - Specified on the CCG 2961 AML treatment protocols --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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
EricSievers, Study Chair, Children's Cancer Group
Children's Hospital of Denver
Denver, Colorado, 80218
United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010-2970
United States
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
United States
Doernbecher Children's Hospital
Portland, Oregon, 97201-3098
United States
IWK Grace Health Centre
Halifax, Nova Scotia, B3J 3G9
Canada
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York City, New York, 10016
United States
Saint Peter's University Hospital
New Brunswick, New Jersey, 08901-9971
United States
Children's Hospital Los Angeles
Los Angeles, California, 90027-0700
United States
British Columbia Children's Hospital
Vancouver, British Columbia, V6H 3V4
Canada
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792
United States
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, 98105
United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
David Grant Medical Center
Travis Air Force Base, California, 94535
United States
Children's Hospital of Columbus
Columbus, Ohio, 43205-2696
United States
Children's Hospital of Orange County
Orange, California, 92868
United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0752
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Vanderbilt Cancer Center
Nashville, Tennessee, 37232-6838
United States
Long Beach Memorial Medical Center
Long Beach, California, 90806
United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213
United States
Wayne Hughes Institute
Roseville, Minnesota, 55113
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637
United States
CCOP - Merit Care Hospital
Fargo, North Dakota, 58122
United States
Herbert Irving Comprehensive Cancer Center
New York City, New York, 10032
United States
Princess Margaret Hospital for Children
Perth, Western Australia, 6001
Australia
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84132
United States
Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
United States
CCOP - Kalamazoo
Kalamazoo, Michigan, 49007-3731
United States
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5265
United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94115-0128
United States
Children's Mercy Hospital
Kansas City, Missouri, 64108
United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033-0800
United States
Veterans Affairs Medical Center - Fargo
Fargo, North Dakota, 58102
United States
Children's Hospital Medical Center - Cincinnati
Cincinnati, Ohio, 45229-3039
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-3330
United States
Center for Cancer Treatment and Research
Columbia, South Carolina, 29203
United States
Additional Information:
Study ID Numbers: CDR0000066930; CCG-B942
Study Start Date: February 1995
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003790
Other Previously Treated Myelodysplastic Syndrome Studies:
1. Decitabine in Treating Patients With Myelodysplastic Syndrome
2. Amifostine and High-Dose Combination Chemotherapy in Treating Patients With Acute Myeloid Leukemia or Chronic Myelogenous Leukemia
3. Donor Bone Marrow Transplantation in Treating Patients With Hematologic Cancer
4. Monoclonal Antibody Therapy in Treating Patients With Primary Myelodysplastic Syndrome
5. Chemotherapy in Treating Patients With Newly Diagnosed Acute or Chronic Myelogenous Leukemia or Myelodysplastic Syndrome
Related Studies:
Other Previously Treated Myelodysplastic Syndrome Clinical Trials
Other Ohio Clinical Trials
Other Columbus Clinical Trials
Detection of Residual Disease in Children Receiving Therapy for Acute Myeloid Leukemia or Myelodysplastic Syndrome
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