S0106B Studying Bone Marrow Samples From Women With Acute Myeloid Leukemia
|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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01575535
|Principal Investigator:||Roland Walter, MD, PhD||Fred Hutchinson Cancer Research Center|