Monitoring Minimal Residual Disease of Patients With Acute Myelogenous Leukemia or High Grade Myelodysplastic Syndrome

Following therapy, the majority of patients with AML and many patients with MDS will achieve
a remission that is defined by the lack of any evidence of the disease when viewing bone
marrow samples under a microscope. Despite the absence of disease by this method, many
patients in remission will still have what is referred to as Minimal Residual Disease when
more sensitive methods are applied. The presence of Minimal Residual Disease following
therapy does not guarantee that the patient will experience a relapse. This is likely a
result of the failure of these techniques to examine those cells that are responsible for
disease relapse. Recent data suggests that in the majority of patients with AML or MDS only a
minor population of the malignant cells are capable of maintaining the disease and are likely
responsible for relapse following therapy. This minor population of cells can be identified
by the proteins they have on their surface. This study tests the ability to identify Minimal
Residual Disease following therapy by performing special assays that specifically target this
minor population of malignant cells.

Inclusion Criteria:

- Are being evaluated for the diagnosis and/or treatment of Acute Myelogenous Leukemia
or High Grade myelodysplastic syndrome (defined as greater than 10 percent blasts on
examination of the bone marrow aspirate).

- Have not undergone prior cytotoxic therapy for acute myelogenous leukemia or High
Grade myelodysplastic syndrome in the past 3 months other than hydroxyurea or
Revlimid.

- Have not previously received an allogeneic peripheral blood or bone marrow stem cell
transplant for their disease.

- Are able to sign an informed consent. Informed consent must be signed at the time of
enrollment and prior to the collection of any specimens and/or clinical data (other
than PHI needed to screen and identify patients, which will be promptly discarded in a
secure fashion if patient is not enrolled on study)

- Are at least 18 years of age.

- Do not have any serious medical or psychiatric illness, other than that treated by
this study which would limit the ability of the patient to receive therapy or give
informed consent.

- Have been informed of the investigational nature of this study and given written
informed consent in accordance with institutional and federal guidelines.

Exclusion Criteria:

- Subjects who are less than 18 years of age.

- Subjects with limited decision making capacity.

- Subjects who have received prior cytotoxic therapy, other than hydroxyurea or
Revlimid, for their disease within the past three months.

- Patients with a diagnosis of chronic myelogenous leukemia in blast crisis, Acute
Promyelocytic Leukemia, or Bi-lineage leukemia.

- Subjects who have previously undergone an allogeneic peripheral blood stem cell
transplant.

- Have an active malignancy other than acute myelogenous leukemia (AML) or
myelodysplastic syndrome (MDS) at the time of evaluation or a prior history of
treatment for a malignancy other than AML or MDS within the past 2 years.