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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00003790
Registration number
NCT00003790
Ethics application status
Date submitted
1/11/1999
Date registered
23/04/2004
Date last updated
6/08/2014
Titles & IDs
Public title
Detection of Residual Disease in Children Receiving Therapy for Acute Myeloid Leukemia or Myelodysplastic Syndrome
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Scientific title
Detection of Minimal Residual Disease in Children Receiving Therapy for AML or MDS
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Secondary ID [1]
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CCG-B942
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Secondary ID [2]
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B942
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Leukemia
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Myelodysplastic Syndromes
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Condition category
Condition code
Cancer
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Leukaemia - Acute leukaemia
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Cancer
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Leukaemia - Chronic leukaemia
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Cancer
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Children's - Leukaemia & Lymphoma
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Blood
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Haematological diseases
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Blood
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Other blood disorders
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Other
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Other interventions - polymerase chain reaction
Other interventions - flow cytometry
Other interventions: polymerase chain reaction
Other interventions: flow cytometry
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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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.
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Assessment method [1]
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Timepoint [1]
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12 months from achievement of remission
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Eligibility
Key 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
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Minimum age
No limit
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Maximum age
21
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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Study design
Purpose
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Duration
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Selection
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Timing
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/02/1995
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/09/2006
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Sample size
Target
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Accrual to date
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Final
496
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment hospital [1]
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Princess Margaret Hospital for Children - Perth
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Recruitment postcode(s) [1]
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6001 - Perth
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Recruitment outside Australia
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United States of America
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California
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Colorado
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District of Columbia
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Illinois
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Indiana
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Iowa
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Minnesota
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Missouri
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Nebraska
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New Jersey
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New York
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North Carolina
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North Dakota
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Ohio
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Oregon
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Pennsylvania
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South Carolina
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Tennessee
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Wisconsin
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Canada
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British Columbia
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Canada
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Nova Scotia
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Funding & Sponsors
Primary sponsor type
Other
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Name
Children's Oncology Group
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Address
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Other collaborator category [1]
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Government body
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Name [1]
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National Cancer Institute (NCI)
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00003790
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Eric Sievers, MD
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Address
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Fred Hutchinson Cancer Center
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00003790
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