S0106B Studying Bone Marrow Samples From Women With Acute Myeloid Leukemia
NCT ID: NCT01575535
Last Updated: 2015-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
100 participants
OBSERVATIONAL
2012-04-30
2012-05-31
Brief Summary
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PURPOSE: This research trial studies bone marrow samples from women with acute myeloid leukemia.
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Detailed Description
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* Estimate the proportion of acute myeloid leukemia (AMLs) that originate in CD33+ precursors or in which uncontrolled growth is limited to CD33+ precursors.
* Explore whether there is an association between the cellular origin of AML (i.e., origination in CD33+ precursors or not) and cytogenetic, molecular, and other patient characteristics.
* Explore whether overall survival (OS), event-free survival (EFS), disease-free survival (DFS), response rate (RR), or relapse rate is improved for patients with AMLs that originate in CD33+ precursors or in which uncontrolled growth is limited to CD33+ precursors compared to patients with clonally involved cells not detected.
OUTLINE: Archived bone marrow samples are analyzed for CD33+ progenitors, X-chromosome inactivation, and somatic mutations (t(8;21), inv(16), FLT3/ITD, NPM1, CEBPA, KIT) by fluorescence-activated cell sorting, long-term culture in hypoxic condition in cytokine-containing liquid media, and flow cytometry. Results are then compared with each patient clinical data.
Conditions
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Study Design
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RETROSPECTIVE
Interventions
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gene expression analysis
flow cytometry
fluorescence activated cell sorting
laboratory biomarker analysis
medical chart review
Eligibility Criteria
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Inclusion Criteria
* Diagnostic bone marrow specimens from female patients with untreated AML undergoing intensive ("3+7"-like) induction chemotherapy
* Specimens from the South Western Oncology Group (SWOG) protocols S0106 (age 18 to 60 years), excluding patients who received gemtuzumab ozogamicin (GO), and S9333 (age \> 60 years)
PATIENT CHARACTERISTICS:
* See Disease Characteristics
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
SWOG Cancer Research Network
NETWORK
Responsible Party
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Principal Investigators
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Roland Walter, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Fred Hutchinson Cancer Center
Other Identifiers
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S0106B
Identifier Type: OTHER
Identifier Source: secondary_id
S0106B
Identifier Type: -
Identifier Source: org_study_id
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