Phase II Study of Histone-deacetylase Inhibitor ITF2357 in Refractory/Relapsed Lymphocytic Leukemia

Inclusion Criteria: * Confirmed diagnosis of CLL according to the NCI Working Group criteria. * Male and female patients of age \>18 and ≤75 years * Patients relapsed/refractory within 1 month after conventional chemotherapy (\>1 polychemotherapy regimen) or relapsed within 3 months after autologous bone marrow transplantation * ECOG performance score of ≤2 * Lymphocytes ≥10.0x10\^9/L and platelets \>75.0x10\^9/L after recovery from a previous therapy * Percentage of CD19+/CD5+ leukemic cells \>50% * Adequate cardiac, pulmonary and renal function, as defined by LVEF \>45%, FEV \>50% and creatinine ≤1.5 ULN or creatinine clearance ≥50ml/min * Serum bilirubin \<1.5xULN, AST and ALT \<2.5xULN * Serum potassium, phosphorus, total calcium, magnesium \>LLN * Normal values for FT4 and TSH (patients may be on thyroid hormone replacement) * Negative test for beta-HCG for women in fertile age * Documentation of written informed consent to participate in the trial * Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures. Exclusion Criteria: * Patients with Autoimmune haemolytic anaemia, Autoimmune Thrombocytopenic Purpura and Fischer Evans Syndrome. * Patients with other autoimmune diseases. * Patients with a marked baseline prolongation of QTc interval (e.g. repeated demonstration of a QTc interval \>450 ms). * Patients with history of additional risk factors for torsade de pointes (e.g. hearth failure, family history of Long QT Syndrome) * The use of concomitant medications with potential risk of torsade de pointes and/or that can prolong QTc interval * Prior treatment with an HDAC inhibitor. * Treatment with Rituximab or Alemtuzumab within 90 days prior to study therapy. * Patients HIV positive, patients with active EBV, HBV, HCV infection or liver cirrhosis * Patients with active uncontrolled viral or bacterial or mycotic infection. * Major surgeries within 4 weeks from study start or not fully recovered from any previous surgical procedure. * Presence of any medical or psychiatric condition which may limit full compliance with the study or increase the risk associated with study participation or study drug administration. * Patients in treatment with corticosteroids within 1 month before study start * Significant cardiovascular disease (i.e., uncontrolled arrhythmias, unstable angina), or a major thromboembolic event (myocardial infarction, stroke, transient ischemic attack, pulmonary embolism, or non-catheter-related deep-vein thrombosis) in the last 6 months. * Uncontrolled hypertension. * Malabsorption syndromes. * Breast feeding women