S0106B Studying Bone Marrow Samples From Women With Acute Myeloid Leukemia
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|ClinicalTrials.gov Identifier: NCT01575535|
Recruitment Status : Completed
First Posted : April 11, 2012
Last Update Posted : March 6, 2015
RATIONALE: Studying samples of bone marrow from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.
PURPOSE: This research trial studies bone marrow samples from women with acute myeloid leukemia.
|Condition or disease||Intervention/treatment|
|Leukemia||Genetic: gene expression analysis Other: flow cytometry Other: fluorescence activated cell sorting Other: laboratory biomarker analysis Other: medical chart review|
- 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.
|Study Type :||Observational|
|Actual Enrollment :||100 participants|
|Official Title:||S0106B, Stem Cell Origin in AML: Prognostic and Therapeutic Implications|
|Study Start Date :||April 2012|
|Actual Primary Completion Date :||May 2012|
|Actual Study Completion Date :||May 2012|
- Association between CD33+ precursors and cytogenetic and/or molecular risks using Fisher's exact test [ Time Frame: May 2012 ]
- Relationship between emergence of individual mutations [t(8;21), inv(16), FLT3/ITD, NPM1, CEBPA, and KIT], clonality, and stage of cell differentiation using Fisher's exact test [ Time Frame: May 2012 ]
- Associations between survival outcomes (OS, EFS, DFS, RR, and relapse rate) and CD33+ restriction using regression analysis [ Time Frame: May 2012 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01575535
|Principal Investigator:||Roland Walter, MD, PhD||Fred Hutchinson Cancer Research Center|