The Development of Predictive Biomarker Models for Patients Receiving Standard Induction Chemotherapy With and Without Gemtuzumab Ozogamicin
OBJECTIVES:
- To determine whether measuring biomarkers in less-differentiated acute myeloid leukemia
(AML) blasts significantly improves their predictive accuracy to predict clinical
outcomes for patients receiving induction/consolidation chemotherapy with and without
gemtuzumab ozogamicin.
- To develop and validate novel predictive biomarker models for predicting clinical
outcomes for AML patients receiving induction/consolidation chemotherapy with and
without gemtuzumab ozogamicin.
OUTLINE: DNA and RNA extracted from archived bone marrow and peripheral blood samples are
analyzed for genomic mutations (CEBPA, FLT3, IDH1/2, KIT, NPM1, RUNX1, TP53, and WT1) and
transcriptional biomarkers (BAALC, CCNA1, CD34, CEBPA, ERG, EVI1, FLT3, IL3RA, MCL1 [two
splice variants], MN1, RUNX1, and WT1) by PCR and real-time PCR. Data are then analyzed by
the Gene Scan software.
Observational
Time Perspective: Retrospective
Biomarker assays in highly purified populations of AML myeloblasts are more predictive of clinical outcomes as compared to the same tests examining unsorted cells
immediate
No
Derek L. Stirewalt, MD
Principal Investigator
Fred Hutchinson Cancer Research Center
United States: Federal Government
CDR0000721439
NCT01503541
December 2011
June 2014
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