Pilot Study to Assess Hematologic Response in Patients With Acute Myeloid Leukemia or High Risk Myelodysplastic Syndromes Undergoing Monotherapy With Exjade (Deferasirox)

Inclusion Criteria:

Patients with high risk MDS or AML Exjade Pilot Assessing Hematologic Response in AML/MDS UPCC# 40413
Newly diagnosed acute myeloid leukemia, not a candidate for intensive induction chemotherapy in the judgement of the investigator or unwilling to undergo intensive induction chemotherapy OR
AML that is refractory or relapsed after treatment with a non-intensive regimen, and not a candidate for allogeneic transplant at this time OR
MDS, IPSS 1.5 or greater, intolerant or with disease progression/lack of response to hypomethylating agents.
Age ≥ 18 years and able to provide independent informed consent
Serum Ferritin: For enrollment on the study: serum ferritin ≥ 500 ng/mL at screening. Samples must be obtained in the absence of concomitant infection. If transfusion is scheduled, draw serum ferritin PRIOR to transfusion.
ECOG performance status 0-2.
Sexually active women must use an effective method of contraception, or must have undergone clinically documented total hysterectomy and/or oophorectomy, or tubal ligation or be postmenopausal (defined as amenorrhea for at least 12 months)

Exclusion Criteria:

Prior therapy with intensive chemotherapy for AML
Prior therapy with iron chelating agents within the last 6 months.
Serum creatinine levels greater than 1.5x above the upper limit of normal
AST or ALT levels greater than 5x the upper limit of normal
Current therapy for AML or MDS (a ≥ 4 week washout period for any agent used to treat AML or MDS prior to first dose of study drug is required).
Current therapy with hydrea to control leukocytosis.
Clinical or laboratory evidence of active Hepatitis B or Hepatitis C (HBsAg in the absence of HBsAb OR HCV Ab positive with HCV RNA positive and ALT above the normal range) infection. In the absence of clinical suspicion for active infection, laboratory testing to assess Hepatitis B or C status will not be required at screening.
Clinical history of HIV positive test result (ELISA or Western blot). Laboratory testing to assess HIV status will not be required at screening.
Clinical or self reported history of drug or alcohol abuse within the 12 months prior to enrollment
ECOG Performance Status > 2
Uncontrolled systemic hypertension
Severe cardiac insufficiency (NYHA III or IV), with uncontrolled and/or unstable cardiac or coronary artery disease not controlled by standard medical therapy
Clinical diagnosis of or history of clinically relevant ocular toxicity related to iron chelation
Systemic diseases (cardiovascular, renal, hepatic, etc.) which in the opinion of the investigator would prevent study treatment
Pregnant or breast feeding women
Treatment with systemic investigational drug within the past 4 weeks or topical investigational drug within the past 7 days or plan to receive other investigational drugs while participating in the study
Other surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of study drug
History of non-compliance to medical regimens or patients who are considered potentially unreliable and/or not cooperative
Hematopoietic stem cell transplant for MDS or AML.
Active CNS leukemia Patients who are found to be ineligible after screening procedures will have the reason for ineligibility documented on the screening log. No further data will be collected in the CRF for these patients.