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