Phase II Study of Histone-deacetylase Inhibitor ITF2357 in Refractory/Relapsed Lymphocytic Leukemia
Status:
Terminated
Trial end date:
2009-04-01
Target enrollment:
Participant gender:
Summary
This is an open label, un-controlled, phase II, pilot clinical trial testing ITF2357 in a
population of CLL patients relapsed after or refractory to conventional chemotherapy or
relapsed after autologus bone marrow transplantation.
Patient will receive ITF 2357 orally at the dose of 100 mg x 2/die for three months with
subsequent dose modifications if requested by the patient's conditions.
Primary objective: To determine overall response-rate, complete response (CR) or partial
response (PR) Secondary objectives: To assess the safety and tolerability of ITF2357; to
assess total rate of responders (complete + partial responders); to determine the 6 months
progression free survival; to determine the effects of the drug on haematological parameters.