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Spots Global Cancer Trial Database for Detection of Residual Disease in Children Receiving Therapy for Acute Myeloid Leukemia or Myelodysplastic Syndrome

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We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Detection of Residual Disease in Children Receiving Therapy for Acute Myeloid Leukemia or Myelodysplastic Syndrome

Official Title: Detection of Minimal Residual Disease in Children Receiving Therapy for AML or MDS

Study ID: NCT00003790

Study Description

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.

Eligibility

Minimum Age:

Eligible Ages: CHILD, ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Long Beach Memorial Medical Center, Long Beach, California, United States

Children's Hospital Los Angeles, Los Angeles, California, United States

USC/Norris Comprehensive Cancer Center, Los Angeles, California, United States

Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California, United States

Children's Hospital of Orange County, Orange, California, United States

UCSF Cancer Center and Cancer Research Institute, San Francisco, California, United States

David Grant Medical Center, Travis Air Force Base, California, United States

Children's Hospital of Denver, Denver, Colorado, United States

Children's National Medical Center, Washington, District of Columbia, United States

University of Chicago Cancer Research Center, Chicago, Illinois, United States

Indiana University Cancer Center, Indianapolis, Indiana, United States

University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States

University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States

CCOP - Kalamazoo, Kalamazoo, Michigan, United States

University of Minnesota Cancer Center, Minneapolis, Minnesota, United States

Mayo Clinic Cancer Center, Rochester, Minnesota, United States

Wayne Hughes Institute, Roseville, Minnesota, United States

Children's Mercy Hospital, Kansas City, Missouri, United States

University of Nebraska Medical Center, Omaha, Nebraska, United States

Saint Peter's University Hospital, New Brunswick, New Jersey, United States

Cancer Institute of New Jersey, New Brunswick, New Jersey, 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

Herbert Irving Comprehensive Cancer Center, New York, New York, United States

Lineberger Comprehensive Cancer Center, UNC, Chapel Hill, North Carolina, United States

Veterans Affairs Medical Center - Fargo, Fargo, North Dakota, United States

CCOP - Merit Care Hospital, Fargo, North Dakota, United States

Children's Hospital Medical Center - Cincinnati, Cincinnati, Ohio, United States

Ireland Cancer Center, Cleveland, Ohio, United States

Children's Hospital of Columbus, Columbus, Ohio, United States

Doernbecher Children's Hospital, Portland, Oregon, United States

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States

Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania, United States

Center for Cancer Treatment and Research, Columbia, South Carolina, United States

Vanderbilt Cancer Center, Nashville, Tennessee, 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 and Regional Medical Center - Seattle, Seattle, Washington, United States

Fred Hutchinson Cancer Research Center, Seattle, Washington, United States

University of Wisconsin Comprehensive Cancer Center, Madison, Wisconsin, United States

Princess Margaret Hospital for Children, Perth, Western Australia, Australia

British Columbia Children's Hospital, Vancouver, British Columbia, Canada

IWK Grace Health Centre, Halifax, Nova Scotia, Canada

Contact Details

Name: Eric Sievers, MD

Affiliation: Fred Hutchinson Cancer Center

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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