Phase II Study of Histone-deacetylase Inhibitor ITF2357 in Refractory/Relapsed Lymphocytic Leukemia
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Open Label, Uncontrolled, Pilot, Phase II Study of Histone-deacetylase Inhibitor ITF2357 Administered Orally to Subjects With Chronic Lymphocytic Leukemia (CLL) Refractory/Relapsed After Conventional Chemotherapy or Relapsed After Autologous Bone Marrow Transplantation|
- To determine overall response-rate, complete response (CR) or partial response (PR) to ITF2357 given at 100 mg x 2/die for up to three months [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
- To assess the safety and tolerability of ITF2357; to assess the rate of total responders (complete+partial responders); to determine the 6 months progression free survival; to determine the effects of the drug on haematological. parameters. [ Time Frame: 13 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||February 2008|
|Study Completion Date:||April 2009|
|Primary Completion Date:||April 2009 (Final data collection date for primary outcome measure)|
CLL is the most frequent type of leukemia in the western world and affects mainly elderly individuals, although about one third of patients are less than 60 years of age at diagnosis.
CLL is a heterogeneous disease characterised by a surprisingly diverse clinical course with patients that may have an overall survival time ranging from months to decades.
CLL accounts for approximately 7000 new cases and 4500 deaths per year in the US.
Chemotherapeutic treatment of CLL is largely ineffective and despite new emerging therapies, CLL still remains an incurable disease.
ITF 2357 is a novel and proprietary molecule synthesized by Italfarmaco S.p.A. Research Laboratories, provided with an established and powerful HDAC-inhibitory activity (see below for further details). It is being developend for a range of possible clinical applications both in oncohaematological conditions and in chronic inflammatory diseases. The former application is consistent with the well known antitumor pharmacological properties of HDAC-inhibitors as a family (i.e. cell-cycle arrest, pro-apoptotic and cell-differentiating effects); the latter application (chronic inflammation) is based of the demonstrated anticytokine effect of ITF 2357.
|Department of Internal Medicine and Public Health, University of Perugia|
|Perugia, Italy, 06074|
|Study Director:||Massimo Martelli, MD||Department of Internal Medicine and Public Health, University of Perugia|