Deferasirox, Cholecalciferol, and Azacitidine in the Treatment of Newly Diagnosed AML Patients Over 65

The majority of new cases of acute myeloid leukemia (AML) are diagnosed in patients older
than 65 years of age. The median age of patients at time of diagnosis is 67 years. Standard
therapies for AML often have significant toxicity and are poorly tolerated by this patient
population. Treatment strategies for elderly patients with AML are limited. In those
patients who do achieve complete remission, duration of remission tends to be short.
Treatment at time of relapse is exceedingly difficult and outcomes are dismal. Thus, there
is need for safer and more effective therapies for elderly patients with AML. This trial is
a novel therapeutic combination of deferasirox (Exjade), cholecalciferol, and azacitidine in
patients 65 years or older with newly diagnosed AML who are not fit for standard induction
chemotherapy or hematopoietic stem-cell transplantation.

Inclusion Criteria:

- 65 or older (must have reached 65th birthday)

- Morphologically confirmed diagnosis of AML, excluding AML-M3

- Must have a Zubrod performance status of 0-3

Exclusion Criteria:

- Patients with known HIV infection are excluded. If HIV infection is suspected based
on clinical condition, testing may be performed at the discretion of treatment team,
but is not mandated prior to enrollment.

- Patients with central nervous system involvement by AML are excluded

- Patients with history of an active cancer (except basal cell and squamous cell
cancers of the skin) within the previous 2 years are excluded