S0106B, Stem Cell Origin in AML: Prognostic and Therapeutic Implications
- 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
- 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.
Time Perspective: Retrospective
Association between CD33+ precursors and cytogenetic and/or molecular risks using Fisher's exact test
Roland Walter, MD, PhD
Fred Hutchinson Cancer Research Center
United States: Food and Drug Administration