A Phase Ib/IIb, Open-label, Multi-center, Study of Oral Panobinostat Administered With 5-Azacitidine (in Adult Patients With Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML), or Acute Myeloid Leukemia (AML).

Inclusion Criteria:

Phase l:

* Patients with cytopathologically confirmed diagnosis of AML according to WHO criteria, excluding acute promyelocytic leukemia who are eligible for Vidaza treatment
* ECOG performance status greater less than or equal to 2

Phase ll:

* Adult patients (age ≥ 18 years) who were candidates for treatment with 5-Aza and present with one of the following:

  * intermediate-2 or high-risk myelodysplastic syndromes according to the International Prognostic Scoring System (IPSS). OR
  * AML with multilineage dysplasia and maximum of 30% blasts (former RAEB-T according to FAB) OR
  * chronic myelomonocytic leukemia (CMML)
* Patients must have had the following laboratory values unless elevations are considered due to MDS or leukemia: AST/SGOT and/or ALT/SGPT ≤ 2.5 x ULN; serum creatinine ≤ 1.5 x ULN; serum bilirubin (total and direct) ≤ 2 x ULN; electrolyte panel within normal ranges (WNL) for the institution.

Exclusion Criteria:

Phase l:

* Prior treatment with deacetylase inhibitors
* Concurrent therapy with any other investigational agent

Phase ll:

* Planned hematopoietic stem-cell transplantation (HSCT)
* Patients with therapy-related MDS
* Patients with therapy-related AML and/or relapsed/refractory AML
* Patients with impaired cardiac function including any of the following:

  * Complete left bundle branch block or use of a permanent cardiac pacemaker, congenital long QT syndrome, history or presence of ventricular tachyarrhythmia, clinically significant resting bradycardia (\<50 beats per minute), QTcF \> 460 ms on screening ECG, or right bundle branch block + left anterior hemiblock (bifascicular block)
  * Presence of unstable atrial fibrillation (ventricular response rate \>100 bpm). Patients with stable atrial fibrillation are eligible provided they do not meet the other cardiac exclusion criteria
  * Previous history of angina pectoris or acute MI within 6 months
  * Screening LVEF \<45% by echocardiography or MUGA
  * Other clinically significant heart disease (e.g. uncontrolled hypertension or history of poor compliance with an antihypertensive regimen).
* Any of concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study. For example:

  * Uncontrolled diabetes
  * Active or uncontrolled infection
  * Uncontrolled hypothyroidism
  * Acute or chronic liver or renal disease
* Patient had evidence of clinically significant mucosal or internal bleeding