Trial Information

Use of the MiCK Assay for Apoptosis to Predict Complete Remission in Acute Myeloid Leukemia

A previous preliminary study performed at Vanderbilt University with funding from the
Leukemia Society of America demonstrated that the response of leukemia cells in vitro to the
chemotherapeutic agent idarubicin in the microculture kinetic assay for apoptosis (MiCK
assay) predicted survival in patients with newly diagnosed acute myeloid leukemia (AML). In
this previous study, achievement of complete response (CR) to induction therapy with
idarubicin and cytarabine was used as the clinical indicator for determining whether
leukemia specimens taken prior to treatment were sensitive or not sensitive in the MiCK
assay. This group of patients has been followed for 7 years and their long term survival
rates show that their responses in the MiCK assay to idarubicin but not cytarabine predict
survival. In the present proposal a separate group of patients with newly diagnosed AML will
be recruited to provide leukemia cell samples that will be used to establish criteria for
sensitivity and non-sensitivity to idarubicin and cytarabine in the MiCK assay. The
achievement of CR will be used to determine in vitro sensitivity as it was done in the
previous study. With the in vitro sensitivities as determined in this proposed study, the
long term survivals of patients in the previous study will be analyzed prospectively.

STUDY DESIGN

1. Recruit patients and assign them unique number at the time of sample collection. All
samples and data will be recorded by unique number. The key to the unique numbers
assigned to each patient will be kept by the principal investigators at Vanderbilt.

2. After obtaining informed consent, collect specimens from patients whose induction
therapy will include cytarabine and idarubicin. Collect and ship to DiaTech by
overnight courier fifty (50) bone marrow or peripheral blood [if available, both bone
marrow and peripheral blood] specimens from newly diagnosed patients with AML. Newly
diagnosed AML patients include those diagnosed de novo or arising from a previously
diagnosed myelodysplastic syndrome, but do not include patients with previously treated
leukemia that has relapsed. An adequate specimen for analysis will contain sufficient
numbers of viable leukemia cells to perform the MiCK assay with 7 doses of cytarabine
and 7 doses of idarubicin..

3. Each patient's clinically recognized predictors of leukemia treatment outcome will be
recorded. These predictors include age, sex, presence or absence of preceding
myelodysplastic syndrome, blood leukocyte count at diagnosis, percentage of leukemic
cells in the blood, and leukemic cell karyotype.