Trial Information

Molecular Genetic Studies of Acute Myeloid Leukemia (AML) With Normal Cytogenetics. A CALGB Leukemia Tissue Bank Project

OBJECTIVES:

- Validate, on the larger number of patients with karyotypically normal acute myeloid
leukemia (AML) treated uniformly on CALGB-19808, preliminary results from CALGB-9621
showing that BAALC and ERG overexpression and microarray gene-expression signatures can
stratify the patients prognostically.

- Establish whether microRNAs are differentially expressed in subsets of patients with
AML and normal cytogenetics, and, if so, attempt to identify a signature that
stratifies patients prognostically.

- Explore the relative contribution in predicting clinical outcome of patients with
cytogenetically normal AML using genetic markers such as BAALC, ERG, and EVI1
overexpression, MLL partial tandem duplication, FLT3 internal tandem duplication, NPM1
and CEBPA mutations, and microarray gene expression microRNA signatures.

OUTLINE: This is a multicenter, pilot study.

Peripheral blood and bone marrow samples are analyzed to assess gene expression using
polymerase chain reaction (PCR) or reverse transcriptase-PCR assays and microarray assays.
Genes to be studied include BAALC, ERB, EVI1, MLL, FLT3, NPM1, and CEBPA.

PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.