A Phase 1, Open-Label, Dose-Escalation & Expanded Cohort, Continuous IV Infusion, Multi-center Study of the Safety, Tolerability,PK & PD of EPZ-5676 in Treatment Relapsed/Refractory Patients With Leukemias Involving

Inclusion Criteria

• •1. Male and female patients aged ≥ 18 years.
• •2. Patients with relapsed /refractory AML, ALL, or MLL with rearrangement of the MLL gene, including 11q23 or PTD, are eligible for the expanded cohort:
• •* At least one prior therapy;
• •* Refractory disease on most recent therapy, or disease recurrence following remission on most recent therapy;
• •* Received and failed all known effective therapies for their disease;
• •* Not a candidate for allogeneic stem cell transplantation
• •* \> 10% blasts or biopsy-documented leukemia cutis or myeloid sarcoma.
• •3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
• •4. Patients must have the following clinical laboratory values:
• •* Serum creatinine ≤2 mg/dL or creatinine clearance \> 60 mL/minute;
• •* Total bilirubin ≤2.0 times the ULN for the institution, unless considered due to Gilbert's syndrome;
• •* ALT or AST ≤ twice the upper limit of normal (ULN), unless considered due to organ leukemic involvement;
• •* Absolute neutrophil count ≥1,000/µL (unless due to documented leukemic involvement of the bone marrow at the time of study entry)
• •* Platelets ≥100,000/µL (unless due to documented leukemic involvement of the bone marrow at the time of study entry).
• •* PT or aPTT \< 1.5 times the ULN
• •5. Able and willing to give written informed consent.
• •6. Life expectancy of at least 3 months