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.

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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.

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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

Study is for people with:

Acute Myeloid Leukemia

Estimated Enrollment:

496

Study ID:

NCT00003790

Recruitment Status:

Completed

Sponsor:

Children's Oncology Group

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There are 42 Locations for this study

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Long Beach Memorial Medical Center
Long Beach California, 90806, United States
Children's Hospital Los Angeles
Los Angeles California, 90027, United States
USC/Norris Comprehensive Cancer Center
Los Angeles California, 90033, United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles California, 90095, United States
Children's Hospital of Orange County
Orange California, 92868, United States
UCSF Cancer Center and Cancer Research Institute
San Francisco California, 94115, United States
David Grant Medical Center
Travis Air Force Base California, 94535, United States
Children's Hospital of Denver
Denver Colorado, 80218, United States
Children's National Medical Center
Washington District of Columbia, 20010, United States
University of Chicago Cancer Research Center
Chicago Illinois, 60637, United States
Indiana University Cancer Center
Indianapolis Indiana, 46202, United States
University of Iowa Hospitals and Clinics
Iowa City Iowa, 52242, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor Michigan, 48109, United States
CCOP - Kalamazoo
Kalamazoo Michigan, 49007, United States
University of Minnesota Cancer Center
Minneapolis Minnesota, 55455, United States
Mayo Clinic Cancer Center
Rochester Minnesota, 55905, United States
Wayne Hughes Institute
Roseville Minnesota, 55113, United States
Children's Mercy Hospital
Kansas City Missouri, 64108, United States
University of Nebraska Medical Center
Omaha Nebraska, 68198, United States
Saint Peter's University Hospital
New Brunswick New Jersey, 08901, United States
Cancer Institute of New Jersey
New Brunswick New Jersey, 08901, United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York New York, 10016, United States
Memorial Sloan-Kettering Cancer Center
New York New York, 10021, United States
Herbert Irving Comprehensive Cancer Center
New York New York, 10032, United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill North Carolina, 27599, United States
Veterans Affairs Medical Center - Fargo
Fargo North Dakota, 58102, United States
CCOP - Merit Care Hospital
Fargo North Dakota, 58122, United States
Children's Hospital Medical Center - Cincinnati
Cincinnati Ohio, 45229, United States
Ireland Cancer Center
Cleveland Ohio, 44106, United States
Children's Hospital of Columbus
Columbus Ohio, 43205, United States
Doernbecher Children's Hospital
Portland Oregon, 97201, United States
Children's Hospital of Philadelphia
Philadelphia Pennsylvania, 19104, United States
Children's Hospital of Pittsburgh
Pittsburgh Pennsylvania, 15213, United States
Center for Cancer Treatment and Research
Columbia South Carolina, 29203, United States
Vanderbilt Cancer Center
Nashville Tennessee, 37232, United States
University of Texas - MD Anderson Cancer Center
Houston Texas, 77030, United States
Huntsman Cancer Institute
Salt Lake City Utah, 84132, United States
Children's Hospital and Regional Medical Center - Seattle
Seattle Washington, 98105, United States
Fred Hutchinson Cancer Research Center
Seattle Washington, 98109, United States
University of Wisconsin Comprehensive Cancer Center
Madison Wisconsin, 53792, United States
Princess Margaret Hospital for Children
Perth Western Australia, 6001, Australia
British Columbia Children's Hospital
Vancouver British Columbia, V6H 3, Canada
IWK Grace Health Centre
Halifax Nova Scotia, B3J 3, Canada

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Estimated Enrollment:

496

Study ID:

NCT00003790

Recruitment Status:

Completed

Sponsor:


Children's Oncology Group

How clear is this clinincal trial information?

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