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


N/A
N/A
21 Years
Open (Enrolling)
Both
Leukemia, Myelodysplastic Syndromes

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Diagnostic

Principal Investigator

Eric Sievers, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Fred Hutchinson Cancer Research Center

Authority:

United States: Federal Government

Study ID:

CDR0000066930

NCT ID:

NCT00003790

Start Date:

February 1995

Completion Date:

Related Keywords:

  • Leukemia
  • Myelodysplastic Syndromes
  • recurrent childhood acute myeloid leukemia
  • untreated childhood acute myeloid leukemia and other myeloid malignancies
  • de novo myelodysplastic syndromes
  • previously treated myelodysplastic syndromes
  • secondary myelodysplastic syndromes
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Myelodysplastic Syndromes
  • Preleukemia
  • Neoplasm, Residual

Name

Location

Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania  19104
Mayo Clinic Cancer CenterRochester, Minnesota  55905
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
USC/Norris Comprehensive Cancer CenterLos Angeles, California  90033-0800
University of Chicago Cancer Research CenterChicago, Illinois  60637
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
University of Iowa Hospitals and ClinicsIowa City, Iowa  52242
University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina  27599-7295
Ireland Cancer CenterCleveland, Ohio  44106-5065
UCSF Cancer Center and Cancer Research InstituteSan Francisco, California  94115-0128
CCOP - KalamazooKalamazoo, Michigan  49007-3731
Vanderbilt Cancer CenterNashville, Tennessee  37232-6838
CCOP - Merit Care HospitalFargo, North Dakota  58122
NYU School of Medicine's Kaplan Comprehensive Cancer CenterNew York, New York  10016
Huntsman Cancer InstituteSalt Lake City, Utah  84112
David Grant Medical CenterTravis Air Force Base, California  94535
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
Herbert Irving Comprehensive Cancer CenterNew York, New York  10032
Veterans Affairs Medical Center - FargoFargo, North Dakota  58102
Cancer Institute of New JerseyNew Brunswick, New Jersey  08901
University of Nebraska Medical CenterOmaha, Nebraska  68198-3330
Long Beach Memorial Medical CenterLong Beach, California  90806
Children's Hospital Los AngelesLos Angeles, California  90027-0700
Children's Hospital of Orange CountyOrange, California  92668
Children's Hospital of DenverDenver, Colorado  80218
Children's National Medical CenterWashington, District of Columbia  20010-2970
Children's Mercy HospitalKansas City, Missouri  64108
Children's Hospital Medical Center - CincinnatiCincinnati, Ohio  45229-3039
Children's Hospital of ColumbusColumbus, Ohio  43205-2696
Doernbecher Children's HospitalPortland, Oregon  97201-3098
Children's Hospital of PittsburghPittsburgh, Pennsylvania  15213
Children's Hospital and Regional Medical Center - SeattleSeattle, Washington  98105
Saint Peter's University HospitalNew Brunswick, New Jersey  08901-1780
Center for Cancer Treatment and ResearchColumbia, South Carolina  29203
Wayne Hughes InstituteRoseville, Minnesota  55113