Assessment and Determination of Chemotherapy Resistance in Newly-Diagnosed or First Relapse Leukemia Patients

Inclusion Criteria:

Newly Diagnosed Subjects

- The subject is male or female, aged 18 years of age or older

- The subject has a diagnosis of acute lymphocytic leukemia (ALL) or acute myelogenous
leukemia (AML); the subject must have a pathology-confirmed diagnosis

- The subject must have a pathology-confirmed diagnosis

- Acute lymphocytic leukemia (ALL) or acute myelogenous leukemia (AML) is defined as
having >25% blasts in the bone marrow and/or peripheral blood

- The subject has not received any chemotherapy or treatment for their acute leukemia
prior to the initial study visit

- The subject is able and willing to provide written informed consent

- The subject is able to understand the study and cooperate with all study instructions

Relapsed Subjects

- The subject is male or female, aged 18 years of age or older

- The subject has a diagnosis of relapsed acute lymphocytic leukemia (ALL) or relapsed
acute myelogenous leukemia (AML)

- The subject must have a pathology-confirmed diagnosis

- Acute lymphocytic leukemia (ALL) or acute myelogenous leukemia (AML) is defined as
having ≥ 25% blasts in the bone marrow and/or peripheral blood

- The subject has received one or more of the pre-identified chemotherapeutic agents
for treatment of their initial acute leukemia diagnosis

- The subject has not received any systemic chemotherapy or treatment for their
relapsed acute leukemia

- Receipt of intrathecal chemotherapy will be permissible

- The subject is able and willing to provide written informed consent

- The subject is able to understand the study and cooperate with all study instructions

Exclusion Criteria:

- The subject has an uncontrolled serious medical or psychiatric illness that, in the
opinion of the investigator, would compromise the subject's safety or collection of
data

- The subject received treatment with an investigational drug within two weeks of the
initial or subsequent study visits

- Subjects under the age of 18