Panobinostat in Combination With Idarubicin and Cytarabine in Patients Aged 65 Years or Older With Newly Diagnosed Acute Myeloblastic Leukaemia (AML)

Inclusion Criteria:

* The patient should, in the investigator's opinion, be able to meet all clinical trial requirements.
* The patient should have voluntarily give the informed consent before performing any study test that is not part of the regular care of the patients.
* Age \> 65 years.
* The patient should be diagnosed with AML according to the standard criteria of the World Health Organisation (WHO) (see Appendix 8).
* The patient should not have received any prior treatment for AML.
* The patient should have a performance status measured by the ECOG scale \<= 2 .
* The patient should have the following laboratory values prior to the start of the treatment:

  * Aspartate transaminase (AST): ≤ 2.5 x the upper normal ranges.
  * Alanine transaminase (ALT): ≤ 2.5 x the upper normal ranges.
  * Total bilirubin: ≤ 1.5 x the upper normal ranges.
  * Alkaline phosphatase: ≤ 2.5 x the upper normal ranges.
  * Serum creatinine ≤ 2 mg/dl.
  * Serum potassium, magnesium, phosphorus, sodium, total calcium (corrected for serum albumin) or ionized calcium within normal limits (WNL) for the institution. Note: Electrolytes (supplemental therapy) should be given to correct values that are \<LLN. Post-correction values must not be deemed to be a clinically significant abnormality prior to patients being dosed.
* Left ventricular ejection fraction measured by echocardiography ≥ 50%

Exclusion Criteria:

* Patients previously receiving treatment with histone deacetylase inhibitors (HDACi).
* Patient will need valproic acid for any medical condition during the study or within 5 days prior to the first panobinostat dose.
* Promyelocytic AML (M3).
* Secondary AML or previous history of MDS.
* Male patients whose sexual partners are women of a fertile age and do not use contraceptive.
* Known brain or leptomeningeal involvement.
* Presence of any limitation affecting the ability of the patient to comply with the treatment.
* Patients receiving any investigational agent in the 30 days prior to inclusion.
* Patient carrier of human immunodeficiency virus (HIV), hepatitis B virus surface antigen or active infection by hepatitis C virus.
* Presence of heart disorders or clinically significant heart diseases, including any of the following:

  * Congenital QT prolongation "long QT syndrome").
  * History or presence of sustained ventricular tachyarrhythmia (patients with a history of atrial arrhythmia are acceptable, but this must be discussed with the sponsor prior to inclusion).
  * Any history of ventricular fibrillation or "torsade de pointes".
  * Bradycardia defined as HR \< 50 bpm. Patients with pacemakers are eligible if HR ≥ 50 bpm.
  * Screening ECG with QTc \> 450 msec.
  * Right bundle branch block + left anterior hemiblock (bifascicular block).
  * Patients with acute myocardial infarction or unstable angina ≤ 6 months before the start of the investigational drug.
  * Any clinically significant heart disease (e.g., NYHA grades III or IV, or baseline LVEF \<45%, uncontrolled hypertension, or history of poor compliance of antihypertensive treatment).
* Gastrointestinal disease making panobinostat absorption significantly difficult.
* Diarrhea \> grade 1 according to CTCAE criteria, version 3.0.
* Any serious or uncontrolled medical condition (e.g., uncontrolled diabetes, or active or uncontrolled infection), including laboratory disorders that could involve unacceptable risks or affect protocol compliance.
* Concomitant administration of drugs with a relative risk of increasing the QT interval or inducing "torsade de pointes" if this treatment cannot be discontinued or replaced by another prior to the start of the test drug.
* Patient has active bleeding diathesis or is currently being treated with therapeutic doses of sodium warfarin (Coumadin®) or other vitamin K active agents Note: mini-dose of Coumadin® (e.g., 1 mg/day) or anti-coagulants given to maintain intravenous line patency, as well as unfractionated or low molecular weight heparin therapy is permitted
* Patients undergoing major surgery in the four weeks prior to the start of the study treatment or not recovering from the treatment adverse events.
* Patients with a history of malignancies in the past five years. Basal cell carcinoma, skin epithelioma and carcinoma of the cervix in situ are excluded.