Bioelectrical Impedance Measurement for Predicting Treatment Outcome in Patients With Newly Diagnosed Acute Leukemia

PRIMARY OBJECTIVES:

I: To determine the feasibility of obtaining standardized phase angle measurements
(bioelectrical impedance measurement) on patients hospitalized for treatment of newly
diagnosed acute leukemia.

II. To evaluate the association between standardized phase angle measured at the start of
therapy and treatment-related outcomes including treatment related mortality (defined as
60-day mortality) III. Evaluate the association of the day 14 standardized phase angle and
treatment related outcomes, 30-day mortality, length of hospitalization, transfer to
intensive care unit during induction, treatment response (14 day bone marrow response,
complete remission), receipt of post-remission therapy, overall survival.

IV. An exploratory analysis investigating associations with the primary and secondary
outcomes using different ways to categorize the baseline standardized phase angle and, for
acute myeloid leukemia (AML) patients, the standardized phase angle measure obtained just
prior to the nadir marrow.

OUTLINE:

Patients undergo bioelectrical impedance phase angle measurement on day 1 of treatment.
Patients with AML undergo a second measurement prior to the nadir marrow. Patients also
undergo bioelectrical impedance measurements prior to any invasive procedures (bone marrow
biopsy, leukapheresis, peripherally inserted central catheter [PICC] line placement, etc.).

After completion of study treatment, patients are followed up for two years.

Inclusion Criteria:

- Hospitalized for newly diagnosed acute leukemia

- Receiving induction treatment while hospitalized

- Willing and able to provide written informed consent

Exclusion Criteria:

- Presence of a pacemaker or defibrillator

- Patients pregnant at the time of enrollment

- Any condition or abnormality which may, in the opinion of the investigator, compromise
the safety of patients

- Unable/unwilling to follow protocol requirements