Pilot Trial of Arsenic + Cytarabine in Patients With Myelofibrosis

Inclusion Criteria

• •1. Patients \> = 18 years with a documented history of myelofibrosis transformed to acute myeloid leukemia using the World Health Organization criteria of \> = 20% blasts in the peripheral blood or bone marrow; the diagnosis of myelofibrosis could be either primary myelofibrosis (myelofibrosis with myeloid metaplasia, agnogenic myeloid metaplasia), post-polycythemia vera or post-essential thrombocytosis.
• •2. Patients \> = 18 years with myelofibrosis (either primary (myelofibrosis with myeloid metaplasia, agnogenic myeloid metaplasia), post polycythemia vera or post essential thrombocytosis) who 1) meet the Mayo Clinic criteria for high risk disease (\> = 2 of the following criteria: hemoglobin \<10 g/dL, WBC \<4 or \>30 x 109/L, platelets \< 100 x 109/L, absolute monocyte count \> = 1 x 109/L) AND 2) have failed to respond to treatment with at least one prior therapy for myelofibrosis (erythropoietic cytokines, androgens, hydrea, interferon, thalidomide, lenalidomide or investigational therapy).
• •3. Patients must have discontinued prior myelofibrosis treatments (with the exception of hydrea, which is permitted for control of leukocytosis) for at least 14 days prior to starting study drug
• •4. ECOG performance status of \< = 2
• •5. Serum creatinine \< = 2.5 times the upper limit of normal
• •6. Serum bilirubin \< = 2.5 times the upper limit of normal
• •7. Serum potassium \>4.0 mEq/dL and serum magnesium \>2.0 mg/dL. If these serum electrolytes are below the specified limits on the baseline laboratory tests, electrolytes will be administered to bring the serum concentrations to these levels before administering arsenic trioxide.